MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PROTEIN URINE/CSF GEN.3; TURBIDIMETRIC, TOTAL PROTEIN

Catalog Number	03333825190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas integra 400 plus serial number was (b)(6).Based on the provided data, a general reagent problem could be excluded because calibration and quality control were acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable total protein urine/csf gen.3 results from the cobas integra 400 plus analyzer.Patient 1 initial result was 275.03 mg/l, and the repeat result in another laboratory was 82.1 mg/l.Patient 2 initial result was 105.5 mg/l, and the repeat result in another laboratory was 68.1 mg/l.
Additional Manufacturer Narrative
Additional information was provided for the dates of the questionable results.Patient 1 occurred on (b)(6) 2025.Patient 2 occurred on (b)(6) 2025.Medwatch field b3 date of event was updated.
Additional Manufacturer Narrative
Due to the limited information provided, the investigation was unable to determine a specific root cause.There was no product problem identified.

• Brand Name: TOTAL PROTEIN URINE/CSF GEN.3
• Common Device Name: TURBIDIMETRIC, TOTAL PROTEIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23659510
• Report Number: 1823260-2025-04882
• Device Sequence Number: 9961714
• Product Code: JIQ
• UDI-Device Identifier: 04015630919536
• UDI-Public: 04015630919536
• Combination Product (Y/N): N
• Initial Reporter Country: AL
• PMA/510(K) Number: K141925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 03333825190
• Device Lot Number: 86777201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/08/2025
• Supplement Date Received by Manufacturer: 12/08/2025; 01/19/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/22/2025; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown