MalfunctionPZI
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Aug 27, 2019 · Event occurred Aug 4, 2019
Report 1219029-2019-00042 · MDR key 8935506
Device
Generic name
Glucose Test System
Manufacturer
Nova Biomedical Corp.Model number
54794Catalog number
54790
Product problems
- Patient Data Problem
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 SAMPLES AND STATSTRIP METER RETURNED TO NOVA FOR EVALUATION.
Description of Event or Problem
NOVA STATSTRIP HOSPITAL METER MIS-SCANNED PATIENT BARCODE ID (B)(6) AND REPORTED GLUCOSE TEST RESULT UNDER THE WRONG PATIENT ID.