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

Catalog Number	10421436190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analyzer serial number was (b(6).For the initial result, a normal reaction was observed on the reaction monitor data provided.An abnormal reaction was observed for the repeat result.Calibration and qc were acceptable.Abnormal aspiration, sample clot detection, sample probe, and sample short alarms were observed on the alarm trace data.The customer used a centrifugation time of 5 minutes at 3000 revolutions per minute (rpm).A precision check was performed.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for bilt3 bilirubin total gen.3 on a cobas c 503 analytical unit.The initial result was 40.3 umol/l.The initial result was held due to auto-validation rules.The repeat result was 4.36 umol/l and was auto-verified.The initial result was believed to be correct.The repeat result is in question.
Additional Manufacturer Narrative
A general reagent issue was excluded as calibration, and qc were acceptable.Based on the customer's centrifugation time of 5 minutes, the investigation determined the event was consistent with preanalytical handling issues.

• 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: 24367589
• Report Number: 1823260-2026-00553
• Device Sequence Number: 21247959
• Product Code: CIG
• UDI-Device Identifier: 07613336235522
• UDI-Public: 07613336235522
• 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): 03/20/2026

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: 07/31/2026
• Device Catalogue Number: 10421436190
• Device Lot Number: 85816901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/20/2026
• 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