PMID- 20351227 OWN - NLM STAT- MEDLINE DCOM- 20100624 LR - 20220716 IS - 1935-5548 (Electronic) IS - 0149-5992 (Print) IS - 0149-5992 (Linking) VI - 33 IP - 4 DP - 2010 Apr TI - Review of adverse events associated with false glucose readings measured by GDH-PQQ-based glucose test strips in the presence of interfering sugars. PG - 728-9 LID - 10.2337/dc09-1822 [doi] AB - OBJECTIVE: To assess the implications of falsely elevated glucose readings measured with glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) test strips. RESEARCH DESIGN AND METHODS: We conducted a review of the Food and Drug Administration's Manufacturer and User Facility Device Experience database and medical literature for adverse events (AEs) associated with falsely elevated glucose readings with GDH-PQQ test strips in the presence of interfering sugars. RESULTS: Eighty-two reports were identified: 16 (20%) were associated with death, 46 (56%) with severe hypoglycemia, and 12 (15%) with nonsevere hypoglycemia. In eight reports (10%), the AE was not described. Forty-two events (51%) occurred in the U.S. Although most events occurred in hospitalized patients, at least 14 (17%) occurred in outpatients. Agents most commonly associated with AEs were icodextrin-containing peritoneal dialysate and maltose-containing intravenous immune globulin. CONCLUSIONS: GDH-PQQ test strips pose a safety risk to insulin-using patients treated with agents containing or metabolized to interfering sugars. FAU - Frias, Juan P AU - Frias JP AD - Departments of Clinical, Medical, and Regulatory Affairs, LifeScan, Milpitas, California, USA. jellison@its.jnj.com FAU - Lim, Christine G AU - Lim CG FAU - Ellison, John M AU - Ellison JM FAU - Montandon, Carol M AU - Montandon CM LA - eng PT - Journal Article PT - Review PL - United States TA - Diabetes Care JT - Diabetes care JID - 7805975 RN - 0 (Blood Glucose) RN - 0 (Reagent Strips) SB - IM CIN - Diabetes Care. 33:948. PMID: 20351231 MH - Blood Glucose/*analysis MH - Blood Glucose Self-Monitoring/*adverse effects/standards MH - *False Positive Reactions MH - Humans MH - *Reagent Strips PMC - PMC2845013 EDAT- 2010/03/31 06:00 MHDA- 2010/06/25 06:00 PMCR- 2011/04/01 CRDT- 2010/03/31 06:00 PHST- 2010/03/31 06:00 [entrez] PHST- 2010/03/31 06:00 [pubmed] PHST- 2010/06/25 06:00 [medline] PHST- 2011/04/01 00:00 [pmc-release] AID - 33/4/728 [pii] AID - 1822 [pii] AID - 10.2337/dc09-1822 [doi] PST - ppublish SO - Diabetes Care. 2010 Apr;33(4):728-9. doi: 10.2337/dc09-1822.