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

Catalog Number	08056960190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable bilirubin total gen.3 result from the cobas c 503 analytical unit.The affected patient also had questionable bil-d gen.2 results.This medwatch will apply to the bilirubin total gen.3.Please refer to the medwatch with a1.Patient identifier: (b)(6) for the bil-d gen.2 assay.The initial result was 5.27 mg/dl, and the repeat result was 17.5 mg/dl.The sample was repeated again with a result of 5.22 mg/dl.A new sample was collected, and the result was 17 mg/dl.The initial result was repeated because it did not match the patient's history.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
It was confirmed that the internal qc was acceptable.In the alarm trace, there were six sample short alarms and three abnormal aspiration alarms.Five of the sample short alarms occurred around the sample pipetting time in the event.This indicates a sample pre-analytical issue.The investigation determined the event was consistent with a preanalytic issue at the customer site.Preanalytic's are within the customer's responsibility.There was no indication of a device malfunction.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22806067
• Report Number: 1823260-2025-02490
• Device Sequence Number: 7656736
• Product Code: CIG
• UDI-Device Identifier: 07613336121078
• UDI-Public: 07613336121078
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: 06/30/2026
• Device Catalogue Number: 08056960190
• Device Lot Number: 86915801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/23/2025
• 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: Male