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

Catalog Number	03333825190
Medical Device Problem Codes	False Positive Result (1227); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The investigation is ongoing.
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 502 module.The initial tpuc3 result was 2.34 g/l.A urine dipstick test was performed and it showed a very low protein concentration.A week later, the sample was repeated and the tpuc3 result was 1.73 g/l.A 1:2 dilution was performed and the result was 0.75 g/l.The sample was repeated again and the result was 0.50 g/l.
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: 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: 17612963
• Report Number: 1823260-2023-02756
• Device Sequence Number: 6746379
• Product Code: JGQ
• UDI-Device Identifier: 04015630919536
• UDI-Public: 04015630919536
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• 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): 09/29/2023

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: 08/31/2024
• Device Catalogue Number: 03333825190
• Device Lot Number: 73011101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/29/2023
• 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