# Presentation: 568570

## Serious Adverse Events Following Falsely Elevated Glucose Measurements Resulting from Administration of an IGIV Product Containing Maltose 

**BPAC Meeting, Gaithersburg, MD, November 4, 2005**

## Adverse Event Case Report Summary

**Ann Gaines, PhD, MT(ASCP)**
**Division of Epidemiology**
**Office of Biostatistics and Epidemiology**
**Center for Biologics Evaluation and Research**

**BPAC Meeting, Gaithersburg, MD, November 4, 2005**

**Artifactual Hyperglycemia**
**Falsely increased glucose results may occur in patients:**
******  ****Who receive parenteral maltose-, parenteral**
**    ****galactose-, or oral d-xylose-containing biologic and**
**    ****drug products.**
******  ****When blood glucose levels are measured by**
**    ****methodologies that are non-specific for glucose in **
**    ****presence of maltose-,  galactose-, or d-xylose-**
**    ****containing products.**

**Clinical Consequence**
**Falsely elevated glucose results due to maltose,**
**galactose, or d-xylose may result in life-threatening or**
**fatal hypoglycemia when:**
******  ****Insulin is inappropriately administered for artifactual**
**    ****hyperglycemia, e.g.,**
-      **glucose-non-specific methodology = 231 mg/dL, yet**
**	** **glucose-specific methodology = 84 mg/dL.**
******  ****Treatment is not provided for actual hypoglycemia, e.g.,**
**	**** ** **glucose-non-specific methodology = 167 mg/dL, yet**
**	**** ** **glucose-specific methodology = 41 mg/dL.**

**Case Reports**
**CBER is aware of 6 case reports involving maltose-**
**containing intravenous immune globulin products and**
**falsely elevated blood glucose measurements.**
**	****  **_**Case**_** ****	****  **_**Location**_**	****         **_**Year**_**	****          **_**Outcome**_** **
** **** ****	****      ****1****	**** ****	****  U.S.****	****  ****	****         2005****	****	****Fatal**
**	****	****	****     ****2****	****  U.K.****	**** ****	****         2002****	****	****Fatal****	****	**
**	****	****	****     ****3****	****  France****	****         2003****	****	****Resolved**
** **** ****	****      ****4****	****    ****	****  France ****	****         2003****	****	****Resolved**
** **** ****	****      ****5****	****	****  Australia****	****         2004****	****	****Resolved**
** **** ****	****      ****6****	****    ****	****  Australia****	****         2004****	****	****Resolved **** ****	**** ****	**

**Case Report 1**
**86-year-old male patient with complicated medical **
**    ****history, including diabetes. **
**Admitted with 4-day history of cellulitis of foot.**
**Received OCTAGAM* for treatment of septic shock.**
**Experienced complicated hospital course.**
**Monitored blood glucose levels [and adjusted insulin**
**    ****doses] primarily with glucose non-specific**
**    ****methodology.**
**Became hypoglycemic then comatose.**
**Expired.**
*** ****IGIV manufactured by Octapharma; contains 10% maltose****.**

**Case Report 1 ****(continued)**
**Blood glucose levels in conjunction with OCTAGAM administration**

**Case Report 1 ****(continued)**
**Blood glucose levels in conjunction with insulin administration**

**Case Report 2**
**Reported to the Medicines and Healthcare Products**
**Regulatory Agency (U.K.) in 2002:**
**50-year-old diabetic male with failing pancreas-renal**
**     ****transplant received OCTAGAM as anti-rejection**
**     ****agent.**
**Based on artifactual hyperglycemia, inappropriate**
**    ****insulin administered.**
**Developed severe hypoglycemia, became comatose,**
**    ****expired.**

**Case Reports 3 and 4**
**Reported to the ****French Health Products Safety Agency**
**in 2003; both cases involved ****3-week-old non-diabetic**
**males:**
**Received OCTAGAM for unknown indications.**
**Developed artifactual hyperglycemia.**
**Recognized or resolved without intervention.**

**Case Reports 5 and 6**
**Reported in **_**Medical Journal of Australia**_** in 2004:**
**64-year-old diabetic female on dialysis received**
**    ****Intragam P* for ITP:**
-      ** ****developed artifactual hyperglycemia.**
**    ** ** ****increased insulin administered.**
-      ** ****developed actual hypoglycemia.**
-      ****** ****resolved without apparent sequelae.**
**35-year-old non-diabetic female on parenteral**
**    ****nutrition received Intragam P* for ITP:**
-      ****** ****developed artifactual hyperglycemia.**
-      ** ****recognized and resolved without intervention.**
*** IGIV manufactured by CSL Limited; contains 10% maltose**

**Unknown Frequency of Adverse Event**
**FDA’s adverse event surveillance for licensed**
**    ****products u****ses primarily ****passive surveillance.**
**Limitations of passive surveillance systems, such as FDA’s MedWatch (e.g., voluntary reporting).**
**Actual incidence rate of artifactual hyperglycemia adverse event (e.g., occurrences per 100,000 patients) unknown.**
**Estimated reporting rate of artifactual hyperglycemia adverse event (e.g., reports per 1,000,000 prescriptions) unknown.**

**Adverse Event Reporting**
**Physicians, other health care professionals, and**
**patients encouraged to submit serious adverse event**
**reports for any FDA-approved product:**
******  ****Directly to FDA:**
-      ** ****by Internet at **_**[http://](http://www.fda.gov/medwatch)**__**[www.fda.gov/medwatch](http://www.fda.gov/medwatch)**_**.**
**    ** ** ****by telephone at 1-800-FDA-1088.**
-       **by fax at 1-800-FDA-0178.**
**    ****  ****by mail at MedWatch, HF-2, 5600 Fishers Lane,**
**        ****Rockville, MD 20852-9787.**
**To FDA through manufacturers or distributors:**
**     ****contact information generally available in**
**     ****professional package inserts or on web sites.**