TOTAL PROTEIN GEN.2
Received Jul 31, 2025 · Event occurred Jul 3, 2025
Report 1823260-2025-02363 · MDR key 22676035
Device
Generic name
Biuret (colorimetric), Total Protein
Manufacturer
Roche DiagnosticsCatalog number
03183734190
Lot number
850556
Product problems
- Incorrect Measurement
- Incorrect Measurement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE REAGENT PACK NEEDED TO BE RECALIBRATED. THE FSE CHECKED THE PROBE ALIGNMENTS, THE GEAR PUMP PRESSURE WAS ADJUSTED, THERE WERE NO LEAKS FOUND, AND THE RINSE HEAD MECHANISM NOZZLES WERE CHECKED AND WERE OKAY. QC AND PRECISION WERE COMPLETED AND PASSED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.
Additional Manufacturer Narrative
THE COBAS 6000 C (501) MODULE SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF 12 QUESTIONABLE TOTAL PROTEIN GEN.2 RESULTS FROM THE COBAS 6000 C (501) MODULE. ONLY THE DATA FOR 1 OF THE PATIENTS WAS PROVIDED, AND IS A REPORTABLE MALFUNCTION. THE PATIENT'S INITIAL RESULT WAS 0.60 G/DL, AND THE REPEAT RESULT FROM ANOTHER INSTRUMENT WAS 6.01 G/DL. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. THE INITIAL RESULTS WERE REPEATED BECAUSE THE DOCTOR OR TECHNICIAN QUESTIONED THE CRITICAL RESULTS.