867-P: Ongoing Manufacturer-Led Clinical Surveillance of Two Blood Glucose Monitoring Test Strip Systems

Abstract

There are no requirements for manufacturers of blood glucose monitoring systems (BGMS) to ensure their products continue to meet accuracy claims post-launch. Reported here is an on-going manufacturer-initiated clinical surveillance programme for two globally distributed BGMS: OneTouch Verio and OneTouch Select Plus, launched in 2009 and 2015 respectively. Test strip batches were randomly and routinely sampled from the manufacturer’s (LifeScan Inc.) finished product and tested in clinic using capillary blood from subjects with diabetes (testing performed by professional staff). BGMS accuracy was determined against a reference instrument (results in Table). A small number of ’control’ batches were also sent to clinic on a repeat basis for on-going assessment of test variability (data not included in analysis). Both products met clinical accuracy requirements for all years as defined by EN ISO 15197:2015 (min. 95% of all BGMS values within ±15 mg/dL of reference at blood glucose (BG) <100 mg/dL or ±15% at BG ≥100 mg/dL). Furthermore, the OneTouch Verio product, available in U.S. markets, met the clinical accuracy criterion as proposed in current FDA guidance (min. 95% of all BGMS values within ±15% of reference at all BG levels). The manufacturer advocates that all manufacturers of glucose monitoring systems for diabetes patients adopt and maintain a similarly robust surveillance program. Disclosure S.J. Setford: Employee; Self; LifeScan Scotland. L.B. Katz: Employee; Self; LifeScan, Inc. M. Grady: Employee; Self; LifeScan, Inc. K. Macleod: Employee; Self; LifeScan Scotland. H. Cameron: None.