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

Catalog Number	08058679190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient urine sample tested for total protein urine/csf gen.3 (tpuc3) on a cobas c 503 analytical unit.The initial result was > 2.00 g/l.The repeat with a x20 dilution was 7.55 g/l.The sample was repeated with a result of 1.49 g/l.None of the results were believed to be correct.The sample was repeated as the results were inconsistent with the urine albumin result of > 400 (unit of measure not provided).
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).
Additional Manufacturer Narrative
Section d4, lot number and expiration date were updated.A 2nd urine sample from the patient was obtained, and the tpuc3 result was 3.32 g/l.The initial report stated: "the c503 analyzer serial number was (b)(6).".Clarification was received that this should say: "the c503 analyzer serial number was (b)(6)." repeat testing was performed on c503 analyzer serial number (b)(6).The initial result of > 2.00 g/l was accompanied by an invalidating data flag (>test).
Additional Manufacturer Narrative
The alarm trace showed several "sample short" and "abnormal aspiration" alarms around the time of the event.Qc results were stable, with results slightly above the target value.A full calibration was performed in sep-2024.The first two calibrations had alarms; the third calibration was successful.The repeat result of 7.55 g/l with a x20 dilution was accompanied by a data alarm that indicated the reagent was stored or handled improperly or had deteriorated.The initial sample was not handled according to specification.The centrifugation time and g-force specified by the manufacturer (10 minutes at 1300-2000g) were not followed, as the customer used a g-force of 2500g for 11 minutes.An expected result was received for the 2nd sample from the patient.As the customer had no issues with other patient samples and the result from a 2nd sample from this patient was acceptable, the event is consistent with a pre-analytical handling issue.The specific cause of the event could not be determined.

• 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: 21688297
• Report Number: 1823260-2025-00869
• Device Sequence Number: 18336509
• Product Code: JIQ
• UDI-Device Identifier: 07613336121535
• UDI-Public: 07613336121535
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 06/06/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 08058679190
• Device Lot Number: 813681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 04/03/2025; 06/03/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/25/2025; 06/06/2025
• 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