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

Catalog Number	08058679190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The creatinine reagent lot number and expiration date were not provided.The tpuc3 reagent lot number was 783083 with an expiration date of 31-may-2025.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient urine sample tested with creatinine assay and total protein urine/csf gen.3 (tpuc3) assay on a cobas c503 analytical unit.The customer alleged that the urine total protein/creatinine ratio result was also discrepant.Creatinine: initial result: 114.0 mg/dl.Repeat result: 5.15 mg/dl.Tpuc3: initial result: 363 mg/dl (accompanied by an invalidating flag).The sample was auto-repeated.1st repeat result: 117 mg/dl (auto-repeated and accompanied by an invalidating flag).The result was reported outside the laboratory.The customer noticed the auto-repeat, questioned the result, and repeated the sample using manual dilution.2nd repeat result: 37 mg/dl (tested with manual dilution and reported outside the laboratory).The final result was 1845 mg/dl.The result of 1845 mg/dl was deemed to be correct.Reportedly, an amended report with the correct result was issued.
Additional Manufacturer Narrative
Sections d1, d2a, d2b, d4, g1 and g4 were updated.The qc was provided for (b)(6) 2024 and(b)(6) 2024 and it was acceptable.There was no indication of a performance issue with the reagent.The calibration data was unreadable and was not evaluated.The alarm trace showed abnormal aspiration and liquid level alarms which can be an indication of poor sample quality.The customer mentioned the results appeared to be due to a technical error in the dilution protocols.The field service engineer (fse) performed hardware checks and verified that the system was performing within specifications.Precision studies were performed and they were within specifications.The troubleshooting actions performed by the customer and the fse resolved the issue.The investigation did not identify a product problem.The cause of the event was due to a user error (technical errors in following the dilution protocols).

• 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 46250-0457
• MDR Report Key: 20526861
• Report Number: 1823260-2024-03071
• Device Sequence Number: 18138481
• Product Code: JIQ
• UDI-Device Identifier: 07613336121535
• UDI-Public: 07613336121535
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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 Expiration Date: 05/31/2025
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/25/2024
• 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 Age: 69 YR
• Patient Sex: Female