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	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 c 501 serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable bilirubin direct gen.2 results from the cobas 6000 c 501 analyzer.The initial result was 0.5 mg/dl.The repeat result was 0.15 mg/dl and was believed to be correct.
Additional Manufacturer Narrative
The field service engineer did not determine a cause.He checked the pump pressures and dispense levels and performed precision testing and qc that passed.The provided calibration and qc were acceptable.The analyer alarm trace showed abnormal probe sucking and sample short errors, which are indicators of possible poor sample quality.Correct pre-analytic sample handling is within the customer's responsibility.The investigation was unable to determine a specific root cause.There is no evidence to suggest a malfunction of the device.

• 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: 24223662
• Report Number: 1823260-2026-00332
• Device Sequence Number: 8392273
• Product Code: CIG
• UDI-Device Identifier: 04015630927531
• UDI-Public: 04015630927531
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 05/07/2026
• 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: 30 YR
• Patient Sex: Female