MalfunctionPZI
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Oct 24, 2019 · Event occurred Oct 8, 2019
Report 1219029-2019-00059 · MDR key 9234573
Device
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 IS ONGOING.
Description of Event or Problem
CUSTOMER REPORTED RECEIVING WRONG RESULTS ON MANUAL TEST FOR PATIENT. IT WAS MENTIONED THAT THE ISSUE WAS OBSERVED WITH THE FOLLOWING TESTS: RAPID HIV, UA MULTISTIX, URASTIX 4 AND WET MOUNT.