TOTAL PROTEIN GEN.2
Received May 14, 2025 · Event occurred Apr 21, 2025
Report 1823260-2025-01481 · MDR key 22017820
Device
Generic name
Biuret Total Protein
Manufacturer
Roche DiagnosticsCatalog number
08058652190
Lot number
838819
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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 0.119 G/DL. THE REPEATED RESULT WAS 7.81 G/DL. THE REPEATED RESULT MATCHED THE PATIENT'S CLINICAL HISTORY.
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC WERE ACCEPTABLE. THE ALARM TRACE SHOWED SEVERAL "ABNORMAL ASPIRATION ALARMS". A HARDWARE PERFORMANCE CHECK SHOWED THAT ROTOR A WAS OUT OF SPECIFICATION. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS CONSISTENT WITH A HARDWARE ISSUE CAUSING THE TRIGLYCERIDES FOR ROTOR A TO BE OUT OF SPECIFICATION. THE INVESTIGATION DID NOT IDENTIFY A SPECIFIC CAUSE OF THE EVENT.