MalfunctionPZI
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Sep 25, 2019 · Event occurred Sep 4, 2019
Report 1219029-2019-00051 · MDR key 9118654
Device
Generic name
Glucose Test System,
Manufacturer
Nova Biomedical Corp.Model number
54794Catalog number
54790
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
NO PATIENT IMPACT OR ADVERSE EVENT REPORTED. INVESTIGATION IS ON-GOING, PATIENT BARCODE AND STATSTRIP METER RETURNED TO NOVA FOR EVALUATION.
Description of Event or Problem
THE STATSTRIP HOSPITAL METER, SN (B)(4), READ THE PATIENT'S ARMBAND BARCODE AS 0449505. THE ACTUAL NUMBER OF THE BARCODE IS 0449585. THE WRONG ID DID NOT HAVE AN ACTIVE VISIT SO THE RESULTS WERE NOT REPORTED. NO PATIENT IMPACT OR ADVERSE EVENT REPORTED.