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

Catalog Number	08056951190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with bil-d gen.2 assay on a cobas pure c 303 analytical unit.Sample 1: initial result: 7.6 umol/l (tested with doumas method).Repeat result: 2.2 umol/l (tested on beckman coulter using jendrassik-grof method).Sample 2 was tested on an unknown date: initial result: 10 umol/l (tested with doumas method).Repeat result: 4.6 umol/l (tested on beckman coulter using jendrassik-grof method).The initial results did not correlate with the patients' medical history, prompting the repeat of the samples.The repeat results were deemed to be correct.No questionable results were reported outside the laboratory.
Additional Manufacturer Narrative
The cobas pure c 303 analytical unit serial number was (b)(6).Qc was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
The data was requested for further investigation, but was not provided by the customer.The general performance of the device was within the expected thresholds since qc and calibration were acceptable.No product issue could be identified.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23414213
• Report Number: 1823260-2025-04400
• Device Sequence Number: 21440560
• Product Code: CIG
• UDI-Device Identifier: 07613336121061
• UDI-Public: 07613336121061
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 11/26/2025

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: 03/31/2026
• Device Catalogue Number: 08056951190
• Device Lot Number: 85182701
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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