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

Catalog Number	08056951190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable bil-d gen.2 (bild2) results from one patient sample tested on the cobas c 503 analytical unit.The reporter noted that the bild2 results were decreasing.The initial bild2 result was 14.4 umol/l (0.8424 mg/dl).The total bilirubin result was 11.2 umol/l.The first bild2 repeat result was 11.2 umol/l (0.6552 mg/dl).The total bilirubin result was 10.4 umol/l.The second bild2 repeat result was 6.8 umol/l (0.3978 mg/dl).The third bild2 repeat result was 1.9 umol/l with a data flag (0.11115 mg/dl).The fourth bild2 repeat result was 11.2 umol/l.
Additional Manufacturer Narrative
The serial number of the customer's cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined the event was consistent with improper sample storage.The product labeling states "specimen collection and preparation -.Protect specimens from exposure to light." the investigation did not identify a product problem based on the information provided.

• 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: 21179021
• Report Number: 1823260-2025-00174
• Device Sequence Number: 8630716
• Product Code: CIG
• UDI-Device Identifier: 07613336121061
• UDI-Public: 07613336121061
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/21/2025

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 Catalogue Number: 08056951190
• Device Lot Number: 839949
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 03/21/2025
• 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: Unknown