MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BILT3 BILIRUBIN TOTAL GEN.3; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	10421410190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable bilt3 bilirubin total gen.3 results for four patient samples on a cobas 6000 c (501) module.Patient 1: the initial result was 24.4 mg/dl, and the repeated result was 1.4 mg/dl.Patient 2: on (b)(6) 2025, the initial result was 0.9 mg/dl, and the repeated result was 2.4 mg/dl.Patient 3: on (b)(6) 2025, the initial result was 14.20 mg/dl, and the repeated result was 0.7 mg/dl.Patient 4: on (b)(6) 2025, the initial result was 6.20 mg/dl, and the repeated result was 0.3 mg/dl.The samples were repeated because the physician questioned the initial results due to the results not matching the patient's clinical history.The repeated results were believed to be correct.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The field service representative inspected and cleaned the sample probe.He performed checks and tests with acceptable results.The investigation is ongoing.
Additional Manufacturer Narrative
Although no specific cause was found, the instrument performance was verified, and the issue appeared to be resolved after the service actions.

• Brand Name: BILT3 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: 22511353
• Report Number: 1823260-2025-02157
• Device Sequence Number: 8745620
• Product Code: CIG
• UDI-Device Identifier: 07613336235508
• UDI-Public: 07613336235508
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/30/2025

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: 10421410190
• Device Lot Number: 85816701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 07/30/2025
• 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 Age: 78 YR
• Patient Sex: Male