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	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable bil-d gen.2 results for two patient samples tested on the cobas c 503 analytical unit.Sample 1 (b)(6) 2026): the initial result was 0.953 mg/dl.The sample was repeated 5 times and the results were 0.131 mg/dl, 0.139 mg/dl, 0.128 mg/dl, 0.129 mg/dl, and 0.133 mg/dl.The sample was repeated 5 more times and the results were 0.132 mg/dl, 0.128 mg/dl, 0.134 mg/dl, 0.135 mg/dl, and 0.132 mg/dl.The sample was repeated once more and the result was 0.136 mg/dl.Sample 2 (b)(6) 2026): the initial result was 0.757 mg/dl.The sample was repeated 5 times and the results were 0.239 mg/dl, 0.231 mg/dl, 0.232 mg/dl, 0.232 mg/dl, and 0.229 mg/dl.The sample was repeated 5 more times and the results were 0.231 mg/dl, 0.228 mg/dl, 0.228 mg/dl, 0.233 mg/dl or 0.223 mg/dl, and 0.231 mg/dl.The sample was repeated two more times and the results were 0.228 mg/dl and 0.224 mg/dl.
Additional Manufacturer Narrative
One additional sample (sample 3) generated discrepant bil-d gen.2 results: sample (b)(6)2026): the initial result was 1.12 mg/dl.The repeat result was 0.135 mg/dl.The sample was repeated 5 times, and the results were 0.129 mg/dl, 0.131 mg/dl, 0.134 mg/dl, 0.134 mg/dl, and 0.129 mg/dl.The sample was repeated 5 more times and the results were 0.135 mg/dl, 0.134 mg/dl, 0.129 mg/dl, 0.131 mg/dl, and 0.126 mg/dl.Qc and calibration are acceptable.A review of the alarm trace revealed several abnormal aspiration errors, indicating sample quality issues.All 3 samples contained microclots, and especially sample 3 was not well separated and contaminated with a gel layer.The investigation determined that the event was due to pre-analytical handling issues.

• 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: 24148831
• Report Number: 1823260-2026-00242
• Device Sequence Number: 8887399
• 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
• Report Date (Section B): 02/27/2026

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: 877768
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/27/2026
• 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: 55 YR
• Patient Sex: Male