MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BILIRUBIN DIRECT GEN.2; CONJUGATED (DIRECT) BILIRUBIN IVD, KIT, SPECTROPHOTOMETRY

Catalog Number	05589061190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable bilirubin direct gen.2 results for 2 patient samples on a cobas 4000 c311 stand alone system.On (b)(6) 2025, sample 1 had an initial direct bilirubin result of 1.605 mg/dl.The sample was repeated, and the result was 1.639 mg/dl.The doctor questioned the result.The repeat result from an external laboratory that uses an abbott analyzer was 0.46 mg/dl.This repeat result was deemed correct.On (b)(6) 2025, sample 2 had an initial direct bilirubin result of 1.969 mg/dl.The repeat result from the external laboratory was 0.56 mg/dl.
Additional Manufacturer Narrative
The root cause of the event was found to be consistent with methodological differences between the roche and competitor assays.It was also found that the patient samples had a hemolysis index of >25.Per product labeling, "hemolysis: no significant interference up to an h index of 25." no product problem was identified.

• Brand Name: BILIRUBIN DIRECT GEN.2
• Common Device Name: CONJUGATED (DIRECT) BILIRUBIN IVD, KIT, SPECTROPHOTOMETRY
• 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: 22883103
• Report Number: 1823260-2025-02603
• Device Sequence Number: 15863231
• Product Code: CIG
• UDI-Device Identifier: 04015630927531
• UDI-Public: 04015630927531
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 05589061190
• Device Lot Number: 86136101
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 01/08/2026
• 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: 1 MO
• Patient Sex: Unknown