TOTAL PROTEIN GEN.2
Received Mar 30, 2026 · Event occurred Mar 7, 2026
Report 1823260-2026-01154 · MDR key 24728041
Device
Generic name
Biuret Total Protein
Manufacturer
Roche DiagnosticsCatalog number
08058652190
Lot number
918054
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGAITON IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE LOW TOTAL PROTEIN GEN.2 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 2.51 G/DL. THIS RESULT DID NOT MATCH THE PATIENT'S HISTORY, SO THE CUSTOMER REPEATED THE SAME SAMPLE ON A DIFFERENT COBAS PRO ANALYZER. THE REPEAT RESULT WAS 7.44 G/DL. THE REPEAT RESULT USING THE SAME ANALYZER WAS 7.50 G/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER CORRECTED THE CELL RINSE FUNCTIONALITY. HARDWARE PERFORMANCE CHECKS WERE PERFORMED, AND THE CUSTOMER REPORTED NO FURTHER ISSUES. THE PROVIDED DATA FOR CALIBRATION AND QC WERE WITHIN SPECIFICATION. THEREFORE, A GENERAL REAGENT OR APPLICATION-RELATED ISSUE WAS EXCLUDED. THE CUSTOMER'S CENTRIFUGATION TIME WAS TOO SHORT ACCORDING TO THE TUBE MANUFACTURER'S RECOMMENDATIONS. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.