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

Catalog Number	08056951190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The field service engineer (fse) found that the initial reagent pack had unusual calibration results.Replacing the reagent pack resolved the issue.No further issues were reported after the service visit.
Event or Problem Description
There was an allegation of questionable bil-d gen.2 results for 1 patient sample on a cobas c 503 analytical unit.The initial bil-d result was 0.7 mg/dl.The customer replaced the reagent with a new reagent pack of the same lot number and repeated the sample.The repeat result was 0.16 mg/dl.The repeat result was deemed correct.

• 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: 23087913
• Report Number: 1823260-2025-03135
• Device Sequence Number: 13187261
• Product Code: CIG
• UDI-Device Identifier: 07613336121061
• UDI-Public: 07613336121061
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K123965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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: 861352
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/18/2025
• 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