TY - JOUR AU1 - AB - 39_BSS100109.qxd 9/1/09 5:41 PM Page 129 Biomedical Safety & Standards Concise, accurate news reports for medical device safety professionals October 1, 2009 BS&S FEATURE Volume 39 Number 17 FDA Warns on Glucose Test Strips IN THIS ISSUE After years of documented problems with glucose dehydrogenase pyrrolo- Recalls & Field quinoline quinine (GDH-PQQ) enzyme test strips for glucose monitoring, the Corrections—Class I FDA issued a formal public health warning regarding their use. These strips Alaris Infusion have been associated with numerous adverse events related to false-positive Systems .....................129 reports of elevated glucose levels. They should not be used in patients who Powersail Coronary are receiving therapeutic products such as drugs or biologic formulations Catheters ..................131 containing the nonglucose sugars maltose, xylose, or galactose. Gel-Filled Infant Teethers.....................132 Use of a GDH-PQQ test strip in such patients produces a falsely elevated Recalls & Field glucose result that may cause the clinician to administer an inappropriate Corrections—Class II insulin dose. The agency further notes that hypoglycemia may go unrecog- Ultrasound System ....132 nized if the patient and clinician rely solely on the result obtained with the Nucleic Sample GDH-PQQ test strips. Preparation ...............132 Hemoglobin Tests .....132 Table 1 lists the test strips (with TI - Oxygen Concentrator JF - Biomedical Safety & Standards DO - 10.1097/01.BMSAS.0000361744.06455.4e DA - 2009-10-01 UR - https://www.deepdyve.com/lp/wolters-kluwer-health/oxygen-concentrator-y4gnX2FO2y SP - 136 EP - 136 VL - 39 IS - 17 DP - DeepDyve ER -