MalfunctionPZI
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Jun 27, 2019 · Event occurred Jun 2, 2019
Report 1219029-2019-00028 · MDR key 8740563
Device
Generic name
Glucose Test System
Manufacturer
Nova Biomedical Corp.Model number
42214Lot number
0318136309
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION ONGOING.
Description of Event or Problem
ON (B)(6) 2019: DISCREPANT GLUCOSE PATIENT RESULTS USING NOVA STATSTRIP HOSPITAL METER WHEN COMPARED TO LAB REFERENCE ANALYZER.