MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TPUC3; TOTAL PROTEIN

Catalog Number	05171954190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's c 701 analyzer is (b)(6).The serial number of the other roche cobas instrument was requested, but not provided.Calibration data was acceptable.Upon review of the alarm trace, frequent sample aspiration and clot alarms were observed.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for two 24-hour urine patient samples tested with total protein urine/csf gen.3 on a cobas 8000 c 701 module.The first sample initially resulted in a total protein value of 751.0 mg/l when tested on the c 701 analyzer on (b)(6) 2024.The value was not considered plausible since the sample resulted in a kappa free light chain result of 5506 mg/l when tested in another laboratory.The sample was sent to a partner laboratory where it was tested on an unknown roche cobas device, resulting in a total protein value of around 750 mg/l.The second sample was tested on the customer's c 701 analyzer on (b)(6) 2024, resulting in a total protein value of 781.1 mg/l.The sample was then diluted 1:5 and repeated on the c 701 on (b)(6) 2024, resulting in a raw value of 65.2 mg/l.The sample was also diluted 1:10 and repeated on the c 701 on (b)(6) 2024, resulting in a raw value of 27.9 mg/l.The second sample was repeated additional times on the customer's c 701 analyzer on (b)(6) 2024, resulting in the following total protein values: 748.5 mg/l without dilution a raw value of 292.8 mg/l after a 1:2 dilution, which calculates to a total value of 585.6 mg/l when accounting for the dilution factor.A raw value of 91.1 mg/l after a 1:4 dilution, which calculates to a total value of 364.4 mg/l when accounting for the dilution factor.A raw value of 34.1 mg/l after a 1:8 dilution, which calculates to a total value of 272.8 mg/l when accounting for the dilution factor.
Additional Manufacturer Narrative
The field service engineer checked the mixer and cleaned it.The investigation determined that the root cause is sample/patient related.The first patient most likely has a gammopathy disorder.The assay is less able to find small protein molecules.For the second patient, a sample recovering a total protein within the primary measuring range should not be diluted.Data shows that less protein is found with increasing dilution.Reaction monitor data for the sample results were not abnormal.The sample may contain proteins that have a selectivity problem in the assay.The investigation did not identify a product issue.

• 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: 20625117
• Report Number: 1823260-2024-03211
• Device Sequence Number: 12600958
• Product Code: JGQ
• UDI-Device Identifier: 04015630925179
• UDI-Public: 04015630925179
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/14/2025

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: 10/16/2024
• Supplement Date Received by Manufacturer: 02/09/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 02/14/2025
• 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