MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PROTEIN URINE/CSF GEN.3; URINE/CSF TOTAL PROTEIN TEST

Catalog Number	08058679190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable total protein urine/csf gen.3 results for 1 patient sample on a cobas c 503 analytical unit.The initial result was 0.63 g/l.The sample was repeated twice on (b)(6) 2024, resulting in values of 0.13 g/l and 0.11 g/l.The customer repeated the sample because a second sample collected from the patient had values similar to the repeat values obtained on (b)(6) 2024.The values from the second sample were not provided.The questionable result was reported outside the laboratory and was questioned by the clinical staff.Due to the result being questioned by the clinical staff, the sample was repeated.An amended report was sent as the repeated result matched the clinical picture for the patient.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).A small amount of precipitates were observed in the sample.The investigation is ongoing.
Additional Manufacturer Narrative
Qc outliers were observed around the date of the event.The calibration data that was provided (for dates (b)(6) 2024) was acceptable.A bubble was observed on top of the surface for one of the samples.On (b)(6) 2024, a sample pipettor error was observed which is consistent with a sample quality issue.The field service representative replaced the probe and spring, performed alignments, and primed the sample tube.Qc passed.The investigation did not identify a product problem.

• Brand Name: TOTAL PROTEIN URINE/CSF GEN.3
• Common Device Name: URINE/CSF TOTAL PROTEIN TEST
• 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: 20203024
• Report Number: 1823260-2024-02637
• Device Sequence Number: 6674946
• Product Code: JIQ
• UDI-Device Identifier: 07613336121535
• UDI-Public: 07613336121535
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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): 12/04/2024

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: 08058679190
• Device Lot Number: 783083
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 12/04/2024
• 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 Sex: Female