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

Catalog Number	03333825190
Medical Device Problem Codes	Incorrect Measurement (1383); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with total protein urine/csf gen.3 assay on a cobas 8000 cobas c 502 module.Initial result: 19.9 mg/dl.Multiple calibrator failures prompted the repeat of the sample on a different analyzer.Repeat result: 8.8 mg/dl.The repeat result was deemed to be correct.Reportedly, an amended report with the correct result was issued.
Additional Manufacturer Narrative
The cobas c 502 module serial number was (b)(6).The sample was a urine sample.The calibration failed after the reagent pack was changed.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration was last performed on (b)(6) 2025.The provided qc showed results outside the acceptable range.The alarm trace showed an abnormal aspiration alarm.The customer was assisted via telephone, and it was found that the customer was using the incorrect calibrator.The customer performed calibration with the required calibrator, precision studies, and sample testing with successful results.The troubleshooting action performed during the customer's assistance resolved the issue.

• 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: 23645694
• Report Number: 1823260-2025-04836
• Device Sequence Number: 15979522
• Product Code: JIQ
• UDI-Device Identifier: 04015630919536
• UDI-Public: 04015630919536
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 867772
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/23/2025
• 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