MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BIL-D GEN.2; BILIRUBIN, DIAZO COLORIMETRY

Catalog Number	08056951190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable bilirubin total gen.3 and bil-d gen.2 results from the cobas c 303 analytical unit.This medwatch will cover bil-d gen.2.Please refer to the medwatch with a1 patient identifier (b)(6) for the bilirubin total gen.3.Patient 1's bilirubin direct result on the c303 was 8.63 umol/l, and the result from the vitros analyzer was 0 umol/l.Patient 2's bilirubin direct result on the c303 was 18.5 umol/l, and the result from the vitros analyzer was 0 umol/l.An additional result of 22.0 umol/l was provided; it was unclear which patient this result is regarding.Clarification was requested but not provided.
Additional Manufacturer Narrative
The cobas c 303 analytical unit serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined that there was no product issue found.

• Brand Name: BIL-D GEN.2
• Common Device Name: BILIRUBIN, DIAZO COLORIMETRY
• 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: 21697496
• Report Number: 1823260-2025-00886
• Device Sequence Number: 9281621
• Product Code: CIG
• UDI-Device Identifier: 07613336121061
• UDI-Public: 07613336121061
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K123965
• 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): 06/03/2025

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: 08056951190
• Device Lot Number: 821190
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 06/03/2025
• 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: 3 MO
• Patient Sex: Unknown