TOTAL PROTEIN GEN.2
Received Sep 9, 2024 · Event occurred Aug 7, 2024
Report 1823260-2024-02596 · MDR key 20171086
Device
Generic name
Biuret Total Protein
Manufacturer
Roche DiagnosticsCatalog number
05171385190
Lot number
760150
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Non Reproducible Results
Patient
44 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED WERE ACCEPTABLE. THE ALARM TRACE (LAST 30 DAYS) SHOWED OCCASIONAL SAMPLE SHORT ALARMS. THE ALARM TRACE (DATE OF EVENT) DID NOT CONTAIN A CONSPICUOUS EVENT. 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 8000 C702 MODULE. THE INITIAL TP2 RESULT WAS 39.3 G/L. THE CUSTOMER QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS REPEATED AND THE RESULT WAS 57.3 G/L.
Additional Manufacturer Narrative
BASED ON THE CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.