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

Catalog Number	05171954190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was (b)(6).The sample and reagent needles were not cleaned regularly, and they were only cleaned when they were found to be dirty.The investigation is ongoing.
Event or Problem Description
We received an allegation of a discrepant result for 1 patient's urine sample tested with total protein urine/csf gen.3 (tpuc3) assay on a cobas 8000 c702 module.On (b)(6) 2025, the initial result was 75 mg/l.On (b)(6) 2025, a new urine specimen was taken from the patient and tested on a mindray instrument using the pyrogallol red molybdenum method in a different hospital, resulting in a urine total protein value of 24 mg/l; the routine urine test was negative.The reporter deemed the initial result from the module was too high.On (b)(6) 2025, the repeat result of the initial patient sample after dilution was 128 mg/l.The questionable result was not reported outside the laboratory, as it did not match the patient's clinical diagnosis.The initial result was deemed to be correct.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event was consistent with an abnormal and conspicuous reaction caused by the usage of non-roche, not supported partner channels reagents, leading to an unknown carry-over interference.

• Brand Name: TOTAL PROTEIN URINE/CSF GEN.3
• Common Device Name: 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: 22650029
• Report Number: 1823260-2025-02337
• Device Sequence Number: 8677856
• Product Code: JGQ
• UDI-Device Identifier: 04015630925179
• UDI-Public: 04015630925179
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071239
• 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
• Report Date (Section B): 08/18/2025

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: 07/31/2025
• Device Catalogue Number: 05171954190
• Device Lot Number: 79939501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/18/2025
• 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 Age: 8 YR
• Patient Sex: Unknown