MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TPUC3; TOTAL PROTEIN

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	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 c702 module is (b)(6).The customer used different dilution factors.Product labeling states "determine samples having higher concentrations via the rerun function.Dilution of samples via the rerun function is a 1:3 dilution.Results from samples diluted using the rerun function are automatically multiplied by a factor of 3." based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter received questionable total protein urine/csf gen.3 (tpuc3) results from one urine patient sample tested on the cobas 8000 c702 module.The initial result of the undiluted patient sample was 265 mg/dl with a data flag.The first repeat result at x2 dilution was 18 mg/dl.The second repeat result at x4 dilution was 6 mg/dl.The third repeat result at x8 dilution was under 4 mg/dl.The fourth repeat result at x10 dilution was under 4 mg/dl. .

• Brand Name: TPUC3
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21197175
• Report Number: 1823260-2025-00190
• Device Sequence Number: 15343276
• Product Code: JGQ
• UDI-Device Identifier: 04015630925179
• UDI-Public: 04015630925179
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 01/21/2025

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 Catalogue Number: 05171954190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/21/2025
• 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