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

Catalog Number	10421436190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable bilt3 bilirubin total gen.3 assay result for a patient sample tested on a cobas c 503 analytical unit.The initial result was 5.0 umol/l.The sample was repeated two times, resulting in values of 214 umol/l and 213 umol/l.The sample was also repeated on the cobas c 303 instrument and the result was 222 umol/l.
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).Qc and calibration were acceptable.The field service engineer (fse) performed a system check.The main pump pressure was inspected and found to be okay.The rinse water required a minor adjustment because the water volume in the cuvette was slightly below the normal limit.Following the service intervention, the controls were completed successfully.The investigation is ongoing.
Additional Manufacturer Narrative
As both calibration and qc data were acceptable, a general reagent problem was not detected.The alarm trace from the event date and the reaction monitor showed no abnormalities.Given that the reported issue did not impact other assays and considering the reaction monitors, the most probable root cause is an insufficient sample volume for the initial result, possibly due to a single pipetting error or a pre-analytical issue such as the presence of a bubble.The investigation found that the cause of the incident is consistent with pre-analytical handling issues.Correct pre-analytic sample handling is within the customer's responsibility.There was no product problem.

• 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: 24290479
• Report Number: 1823260-2026-00432
• Device Sequence Number: 10213039
• Product Code: CIG
• UDI-Device Identifier: 07613336235522
• UDI-Public: 07613336235522
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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): 03/05/2026

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 Catalogue Number: 10421436190
• Device Lot Number: 88805001
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/05/2026
• 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: Female