FDA Adverse Event
Malfunction
Summary report: N
TOTAL PROTEIN URINE/CSF GEN.3
MDR report key: 24734255
·
Received March 30, 2026
Report
- Report Number
- 1823260-2026-01171
- Event Type
- Malfunction
- Date Received
- March 30, 2026
- Date of Event
- March 10, 2026
- Report Date
- March 30, 2026
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JIQ
- UDI-DI
- 04015630919536
- PMA / PMN Number
- K141925
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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 · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 167320 | TOTAL PROTEIN URINE/CSF GEN.3 | TURBIDIMETRIC, TOTAL PROTEIN | JIQ | ROCHE DIAGNOSTICS | 894344 | 04015630919536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |