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	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number is (b)(6).The calibration results were within the specified ranges.The qc results were within the specified ranges.The alarm trace did not indicate any issues.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable bil-d gen.2 (bild2) results from two patient samples tested on the cobas c 503 analytical unit.Patient sample 1: on (b)(6) 2025: the initial result was 0.789 mg/dl.The repeat result was 0.312 mg/dl.The repeat result was 0.309 mg/dl.Patient sample 2: on (b)(6) 2025: the high result was 0.488 mg/dl.The repeat result was 0.161 mg/dl.
Additional Manufacturer Narrative
The customer reported new questionable bil-d gen.2 (bild2) results from one patient sample tested on the cobas c 503 analytical unit.On (b)(6) 2025: patient sample 3 the initial result was 0.488 mg/dl.The repeat result was 0.161 mg/dl.
Additional Manufacturer Narrative
The investigation included a review of the calibration, qc data, alarm trace, and reaction monitor: the calibration results were within the specified ranges.The qc results were within the specified ranges.The alarm trace did not indicate any issues.The initial result of patient sample 1's reaction monitor showed a conspicuous reaction.A general reagent problem was ruled out because the calibration and qcs before the event were within the specified ranges.The investigation determined the event was consistent with a preanalytic issue at the customer site.Preanalytics are within the customer's responsibility.There was no indication of a device malfunction.The investigation did not identify a product problem.

• 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: 22182981
• Report Number: 1823260-2025-01787
• Device Sequence Number: 20933005
• Product Code: CIG
• UDI-Device Identifier: 07613336121061
• UDI-Public: 07613336121061
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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,Followup
• Report Date (Section B): 08/15/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 07/31/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/07/2025; 08/15/2025
• 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