MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TPUC3; TURBIDIMETRIC, TOTAL PROTEIN

Catalog Number	03333825190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas 6000 c501 module was not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable high tpuc3 total protein urine/csf gen.3 results from one urine patient sample tested on the cobas 6000 c501 module.The initial tpuc3 result of the undiluted patient sample from the module was 152.6 mg/dl.The repeat result with the patient sample at 1:3 dilution from the module was 1193.4 mg/dl.The repeat result of the undiluted patient sample from the module was 132.6 mg/dl.The repeat result using an immunoturbidimetry laboratory method was 15.6 mg/l.The reporter sent the patient sample to an outsourced laboratory.The repeat result from a competitor analyzer using an immunoturbidity laboratory method was 5.5 mg/l.The patient sample was also sent to the investigation laboratory.The repeat result using a benzontium chloride method was 155.2 mg/dl.The investigation laboratory suspects the presence of an interferent in the patient sample.Additional tpuc3 results of 22.4 mg/dl and 397.8 mg/dl were provided.It is not clear how these results relate to the event.Clarification has been requested related to these results but has not been provided.
Additional Manufacturer Narrative
Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: TPUC3
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19192430
• Report Number: 1823260-2024-01289
• Device Sequence Number: 8473818
• Product Code: JGQ
• UDI-Device Identifier: 04015630919536
• UDI-Public: 04015630919536
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 06/25/2024

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: 12/31/2024
• Device Catalogue Number: 03333825190
• Device Lot Number: 75158401
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 06/25/2024
• 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: 4 YR
• Patient Sex: Male