MalfunctionCEK
TOTAL PROTEIN GEN.2
Received Dec 4, 2024 · Event occurred Oct 22, 2024
Report 1823260-2024-03521 · MDR key 20848154
Device
Generic name
Biuret Total Protein
Manufacturer
Roche DiagnosticsCatalog number
05171385190
Lot number
ASKU
Product problems
- Output Problem
- Non Reproducible Results
- Output Problem
- 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. BASED ON THE PROVIDED INFORMATION, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 8000 C702 MODULE IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE TP2 TOTAL PROTEIN GEN.2 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 5.08 G/DL. THE REPEAT RESULT WAS 7.0 G/DL..