TOTAL PROTEIN/TOTAL PROTEIN STAT
Received Sep 26, 2024 · Event occurred Aug 26, 2024
Report 1823260-2024-02791 · MDR key 20311571
Device
Generic name
Biuret (colorimetric), Total Protein
Manufacturer
Roche DiagnosticsCatalog number
03183734190
Lot number
807787
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TP2 TOTAL PROTEIN GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 502 MODULE. THE INITIAL TP2 RESULT WAS 3 G/L. THE CUSTOMER QUESTIONED THE INITIAL LOW RESULT WHICH PROMPTED THEM TO REPEAT THE PATIENT SAMPLE. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 53.6 G/L.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.