MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TPUC3; TOTAL PROTEIN

Catalog Number	05171954190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient urine sample tested with total protein urine/csf gen.3 (tpuc3) assay on a cobas 8000 cobas c701 module when compared to a non-roche analyzer (siemens: athelica system).On (b)(6) 2024: the sample was tested and the initial result was 450 mg/dl.The sample was also tested on siemens (athelica system), resulting in a tpuc3 value of 0.29 g/l.On (b)(6) 2024 the sample was repeated and the 1st repeat result was 357 mg/dl.On (b)(6) 2024 the sample was also repeated and the 2nd repeat result was 389 mg/dl.
Additional Manufacturer Narrative
The tpuc3 reagent expiration date was not provided.The cobas c701 module serial number was (b)(6).Qc was acceptable.The alarm trace showed multiple abnormal aspiration (sample probe) alarms.The customer suspected an interference.The investigation is ongoing.
Additional Manufacturer Narrative
Section b7 was updated.The calibration was acceptable.The alarm trace showed frequent incubation water exchange alarms and a couple of cell blank alarms.Since the patient did not take any medication, no substance was available that could analytically interfere with the tpuc3 assay.The root cause was consistent with an issue with the sample quality or a possible physiological effect of the patient's disease causing proteinuria.There is no evidence to reasonably suggest that the roche assay did not function as intended.The investigation did not identify a product problem.The 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: 19027099
• Report Number: 1823260-2024-01014
• Device Sequence Number: 7354928
• Product Code: JGQ
• UDI-Device Identifier: 04015630925179
• UDI-Public: 04015630925179
• Combination Product (Y/N): Y
• Initial Reporter Country: PO
• 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): 04/30/2024

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: 05171954190
• Device Lot Number: 730461
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 13 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic