TOTAL PROTEIN GEN.2
Received Jan 30, 2024 · Event occurred Dec 21, 2023
Report 1823260-2024-00259 · MDR key 18606696
Device
Generic name
Biuret Total Protein
Manufacturer
Roche DiagnosticsCatalog number
08058652190
Lot number
76240601
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 INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) REPLACE A BENT AND DIRTY SAMPLE PROBE, ADJUSTED THE SAMPLE AND REAGENT PROBES, ADJUSTED THE GEAR PUMP PRESSURE, REPLACED THE CUVETTES AND LAMP, ADJUSTED THE BLANK CELL WATER DISTRIBUTION IN THE CUVETTES, AND PERFORMED A HARDWARE CHECK AND QC SUCCESSFULLY. 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 PRO C 503 ANALYTICAL UNIT. THE INITIAL TP2 RESULT WAS 6 G/L. THE CUSTOMER QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT AND WAS PROMPTED TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 54 G/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.