MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TPUC3; TOTAL PROTEIN

Catalog Number	08058679190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer observed that the sample probe was dirty and has to be cleaned every day since the last service visit.Qc data showed some imprecision.One "abnormal aspiration" alarm was observed in the alarm trace data.The investigation is ongoing.H3 other text : na.
Event or Problem Description
The initial reporter stated they received discrepant results for one urine patient sample tested with tpuc3 (total protein urine/csf gen.3) on a cobas c 503 analytical unit serial number (b)(6).On (b)(6) 2023, the sample initially resulted in a tpuc3 value of 1.40 g/l.This result was reported outside of the laboratory and questioned by the physician.On (b)(6) 2023, the sample was repeated resulting in a tpuc3 value of 0.0835 g/l.This result is consistent with the very low concentration results obtained with the urine strip test.
Additional Manufacturer Narrative
The reaction monitor data showed abnormalities.The customer did not provide any additional information for the investigation.Based on a review of worldwide data of qc recovery, a general reagent issue was excluded.Based on the limited information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17375977
• Report Number: 1823260-2023-02405
• Device Sequence Number: 15257461
• Product Code: JGQ
• UDI-Device Identifier: 07613336121535
• UDI-Public: 07613336121535
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/29/2023

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: 03/31/2024
• Device Catalogue Number: 08058679190
• Device Lot Number: 69928301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/29/2023
• 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 Sex: Unknown