MalfunctionCEK
TOTAL PROTEIN GEN.2
Received May 5, 2026 · Event occurred Apr 9, 2026
Report 1823260-2026-01744 · MDR key 25083265
Device
Generic name
Biuret Total Protein
Manufacturer
Roche DiagnosticsCatalog number
08058652190
Lot number
932865
Product problems
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 703 ANALYTICAL UNIT. THE INITIAL RESULT WAS 3.11 G/DL. THE SAMPLE WAS REPEATED ON ANOTHER C703 ANALYZER AND THE RESULT WAS 5.65 G/DL.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. THE ALARM TRACE DID NOT CONTAIN A CONSPICUOUS EVENT. THE INVESTIGATION IS ONGOING.