MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BILIRUBIN TOTAL GEN.3; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	05795397190
Medical Device Problem Codes	Low Test Results (2458); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with bil-t gen.3 (bilt3) assay on a cobas 6000 c501 (ul) v module.Initial result: <0.2 mg/dl (using micro sample cups).The physician questioned the initial result and the sample was then repeated.Repeat result: 13.3 mg/dl (using a false bottom tube).The repeat result was deemed to be correct as it matched the patient's clinical picture.
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).Qc was within the ranges.The field service engineer checked the instrument and found that it was performing within specifications.He also performed precision studies and they were within specifications.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration was last performed on 12-jan-2025 and it was acceptable.The alarm trace showed sample short, abnormal probe sucking, and abnormal sample aspiration alarms.These are indicators of possible poor sample quality.The customer suspected that the issue was due to using micro-cups.A service visit was offered to verify the micro cup performance, but the customer declined it as they, allegedly, will not be using micro cups in the future.No further issues were reported afterward.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: BILIRUBIN TOTAL GEN.3
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• 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: 21421844
• Report Number: 1823260-2025-00498
• Device Sequence Number: 7913778
• Product Code: CIG
• UDI-Device Identifier: 04015630928897
• UDI-Public: 04015630928897
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131544
• 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): 03/27/2025

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: 11/30/2025
• Device Catalogue Number: 05795397190
• Device Lot Number: 79782801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/27/2025
• 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