MalfunctionCGL
NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM
Received Jul 18, 2019 · Event occurred Jun 24, 2019
Report 1219029-2019-00034 · MDR key 8804722
Device
Generic name
Electrode, Ion Based, Enzymatic, Creatinine
Manufacturer
Nova Biomedical Corp.Model number
43370Lot number
4918333129
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 ONGOING. EVALUATION OF RETAIN STRIPS AND DHR REVIEWS FOR BOTH THE METER AND TEST STRIP BATCH TO BE COMPLETED. QC RESULTS BEFORE AND AFTER THE REPORTED INCIDENT WERE IN RANGE, METER WAS NOT RETURNED FOR INVESTIGATION. THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WAS A DIFFICULT STICK AND THE FINGERSTICK WAS ATTEMPTED TWICE.
Description of Event or Problem
DISCREPANT CREATININE RESULTS USING NOVA STATSENSOR METER. NO ADVERSE EVENT WAS REPORTED.