MalfunctionPZI
STATSTRIP GLUCOSE METER SYSTEM
Received May 11, 2021 · Event occurred Apr 13, 2021
Report 1219029-2021-00020 · MDR key 11809037
Device
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COMPLAINT SAMPLE HAS NOT RETURNED TO NOVA AS OF YET; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. FURTHER INVESTIGATION IS BEING COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.
Description of Event or Problem
THE CUSTOMER REPORTED DISCREPANT PATIENT RESULTS. A TEST WAS RUN ON (B)(6) ON THE STATSTRIP 1.75 METER SN: (B)(4) AND A FLOW ERROR OCCURRED. IT WAS RERUN AND WAS LESS THAN 10, A DRAW WAS DONE AND IT WAS 532. THE PATIENT WAS MOVED TO ANOTHER FLOOR AND TESTED WITH ANOTHER METER AND RECEIVED GOOD RESULTS. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION.