Case Reports: Case Report
It is regrettable that yet another patient suffering iatrogenic hypoglycemia-induced irreversible brain injury resulting from a glucose meter error is reported.1 A number of older meters still in service, using glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) as the enzyme for detecting glucose, misread maltose, a breakdown product of the peritoneal dialysis fluid icodextrin, as glucose. Despite the warning issued by the Food and Drug Administration (FDA) in 2009 specifically concerning icodextrin,a maltose-containing products such as immune globulins,b and the issue being highlighted in a number of publications on the subject,2 awareness of this potentially lethal error clearly remains dangerously low among anesthesiologists, critical care physicians, and nurses.
Manufacturers of portable glucose meters have recognized the importance of the problem by redesigning their newer point-of-care devices to use alternative enzyme systems. However, there is still the potential for this lethal mistake to occur again in the form of thousands of GDH-PQQ glucose meters remaining in routine use in operating rooms and intensive care units. When combined with recent trends advocating “tight” control of glucose in the perioperative period, the lack of specificity of the GDH-PQQ enzyme system creates a pervasive latent error demanding a systems-based approach to ensure that it never again harms another patient. Articles, editorials, and online warnings are clearly insufficient. Now that there are portable alternative means of measurement, we would ask the FDA to take the radical but necessary step of recalling GDH-PQQ glucose meters from all health care facilities where the vulnerability of error deriving from this technology is greatest.
Unusual complications such as this often only come to light after a medical device or drug enters widespread use. This article by Disque et al.1 illustrates the persistent value to practicing clinicians of case reports that reveal rare events and that are typically not discovered in randomized controlled trials. Last, we would encourage health professionals to report serious device errors or malfunctions to the FDA Manufacturer and User Facility Device Experience (MAUDE) database.c
Andrew Pitkin, MD
Mark J. Rice, MD
Department of Anesthesiology
University of Florida College of Medicine, Gainesville, Florida
a FDA. FDA Public Health Notification: Potentially fatal errors with GDH-PQQ glucose monitoring technology. August 13, 2009. Available at: http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm176992.htm Accessed June 26, 2013. Cited Here...
b Gaines AR, Pierce LR, Bernhardt PA. Fatal iatrogenic hypoglycemia: falsely elevated blood glucose readings with a point-of-care meter due to a maltose-containing intravenous immune globulin product. Available at: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm155099.htm Accessed June 26, 2013. Cited Here...
c FDA. MAUDE—Manufacturer and User Facility Device Experience. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. Accessed June 26, 2013. Cited Here...
1. Disque A, Dhillon A, Gritsch A.. Icodextrin causing glucose meter error and severe hypoglycemia after deceased donor renal transplant in a patient receiving continuous ambulatory peritoneal dialysis. A case report. Anesth Analg.
2. Rice MJ, Pitkin AD, Coursin DB. Review article: glucose measurement in the operating room: more complicated than it seems. Anesth Analg. 2010;110:1056–65