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

Catalog Number	03333825190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas 8000 cobas c 502 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable tpuc3 total protein urine/csf gen.3 results from one urine patient sample tested on the cobas 8000 cobas c 502 module.The reporter was not able to provide the date the event occurred.The date the event was reported was used as the date of event.The patient sample was run in unit 1 and unit 2 of the module.The initial result of the undiluted patient sample from unit 1 was 248 mg/dl.The repeat result with the patient sample at an unknown dilution from unit 1 was 132 mg/dl.The initial result of the undiluted patient sample from unit 2 was 247 mg/dl.The repeat result with the patient sample at an unknown dilution from unit 2 was 141 mg/dl.The reporter performed a dilution series for result confirmation.The unit of the module used was not provided.The repeat result of the undiluted sample was 259 mg/dl.The repeat result with the patient sample at a 2-fold dilution was 108 mg/dl with a final dilution result of 216 mg/dl.The repeat result with the patient sample at a 4-fold dilution was 46 mg/dl with a final dilution result of 184 mg/dl.The repeat result with the patient sample at an 8-fold dilution was 18 mg/dl with a final dilution result of 144 mg/dl.The reporter deemed the results of the undiluted patient samples were correct.
Additional Manufacturer Narrative
Medwatch fields a.Patient information, b7 other relevant history, and d10 concomitant medical products updated.The customer reported the tpuc3 result of 216 mg/dl.Based on the information provided, the investigation did not identify a product problem.

• 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: 19524283
• Report Number: 1823260-2024-01749
• Device Sequence Number: 8541032
• 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): 08/21/2024

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 Catalogue Number: 03333825190
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DEXAMETHASONE; FEBUXOSTAT; NALDEMEDINE TOSILATE; OXYCODONE
• Patient Age: 73 YR
• Patient Sex: Female