Review of adverse events associated with false glucose readings measured by GDH-PQQ-based glucose test strips in the presence of interfering sugars.
OBJECTIVE
To assess the implications of falsely elevated glucose readings measured with glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) test strips.


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.
Frias
Juan P
JP
Departments of Clinical, Medical, and Regulatory Affairs, LifeScan, Milpitas, California, USA. jellison@its.jnj.com
Lim
Christine G
CG
Ellison
John M
JM
Montandon
Carol M
CM
D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000009:adverse effects* / Q000592:standards; D005189:False Positive Reactions; D006801:Humans; D011934:Reagent Strips
D001786:Blood Glucose; D011934:Reagent Strips