MalfunctionJIQ
TOTAL PROTEIN URINE/CSF GEN.3
Received Mar 30, 2026 · Event occurred Mar 10, 2026
Report 1823260-2026-01171 · MDR key 24734255
Device
Generic name
Turbidimetric, Total Protein
Manufacturer
Roche DiagnosticsCatalog number
03333825190
Lot number
894344
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. DUE TO THE LIMITED INFORMATION, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULT FOR A URINE PATIENT SAMPLE TESTED ON THE COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL RESULT WAS 280 MG/L. THE REPEAT RESULT WAS 67 MG/L.