Review of Adverse Events Associated With False Glucose Readings Measured by GDH-PQQ–Based Glucose Test Strips in the Presence of Interfering Sugars

Abstract

OBJECTIVETo assess the implications of falsely elevated glucose readings measured with glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) test strips.RESEARCH DESIGN AND METHODSWe 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.RESULTSEighty-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.CONCLUSIONSGDH-PQQ test strips pose a safety risk to insulin-using patients treated with agents containing or metabolized to interfering sugars.

Clinical evaluation of the FreeStyle Precision Pro system

“…However the likelihood of occurrence is near improbable because: (1) xylose blood concentration is high enough to interfere only within a 24-hour window immediately following the xylose administration for the absorption test since the absorbed xylose is rapidly excreted in urine [14]; and (2) the xylose absorption test is rarely performed in medical centers today. This explains why there has not been any reported adverse event caused by xylose interference [15][16][17] even though test strips sensitive to xylose have been in use in health care facilities for over 10 years. For assessment of system accuracy, mean absolute bias, also known as mean absolute relative difference (MARD), is a measure of the average disparity between test device results and the comparative method results.…”

Nickel-phendione complex covalently attached onto carbon nanotube/cross linked glucose dehydrogenase as bioanode for glucose/oxygen compartment-less biofuel cell

“…The GDH may contain one of three cofactors: pyrroloquinoline quinone (PQQ) [5], nicotinamide adenine dinucleotide (NAD) [6] and flavin adenine dinucleotide (FAD) [7]. Among these, PQQ-GDH has the disadvantage of low selectivity caused by the oxidation of a variety of saccharides such as mannose, maltose, lactose, etc [8] and FAD-GDH based sensors also have disadvantages, such as a complicated preparation process, high-cost, and difficult operation. Although the NAD-GDH type exhibits higher substrate selectivity and stability than PQQ-GDH, finding an adequate electron-transfer mediator for a NAD-GDH system is difficult.…”

How reliable are capillary blood glucose measurements?

“…In GDH-based systems, GDH-FAD and GDH-NAD strips do not cross react with sugars other than glucose, whereas GDH-PQQ is non specific. Maltose, galactose and xylose will be misinterpreted as glucose by GDH-PQQbased sensors (3,11).…”

“…FDA advices to avoid using GDH-PQQ glucose test strips in health care facilities and cautions that if they are used "NEVER use them on patients who are receiving interfering products". A possible technical solution to the problem is the use of mutant forms of GDH-PQQ involving amino acid substitution, which have good enzymatic activity for glucose but reduced reactivity for other-sugars (3,11).…”