MalfunctionPZI
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received May 22, 2019 · Event occurred Apr 22, 2019
Report 1219029-2019-00008 · MDR key 8631717
Device
Generic name
Glucose Test System
Manufacturer
Nova Biomedical Corp.Model number
42214Lot number
0317163309
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 IN PROCESS, METER EXPECTED TO BE RETURNED BY CUSTOMER. CUSTOMER NOTED THAT TWO DISCREPANT PATIENT RESULTS REPORTED BY THE FIRST NOVA STATSTRIP METER WERE USING THE LAST 2 TEST STRIPS FORM THAT VIAL. CUSTOMER ALSO STATED THAT THEY COULD NOT CONFIRM THAT THE STRIP VIAL WAS PROPERLY HANDLED.
Description of Event or Problem
DISCREPANT GLUCOSE RESULTS USING NOVA STATSTRIP METER COMPARED TO A NON-NOVA METER AND A SECOND NOVA STATSTRIP METER.