MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TPUC3; TOTAL PROTEIN

Catalog Number	05171954190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable tpuc3 total protein urine/csf gen.3 results for 1 patient urine sample on a cobas 8000 cobas c 701 module.The initial urine tpuc3 result was 1.4 g/l.The customer was prompted to repeat the sample as they result did not match the patient's clinical diagnosis.The repeat result was 0.5 g/l.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The field service engineer (fse) confirmed that the analyzer was functioning.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 18543071
• Report Number: 1823260-2024-00179
• Device Sequence Number: 15417085
• Product Code: JGQ
• UDI-Device Identifier: 04015630925179
• UDI-Public: 04015630925179
• Combination Product (Y/N): Y
• 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): 03/01/2024

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: 05171954190
• Device Lot Number: 750333
• 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: 12/25/2023
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 03/01/2024
• 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: 57 YR
• Patient Sex: Female