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	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 4000 c311 stand alone system serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable bilirubin direct gen.2 result from the cobas 4000 c311 stand alone system.The initial result was 1.025 mg/dl.The pediatrician requested a new blood sample to be analyzed at another laboratory using an abbott analyzer.The result for the new sample was 0.50 mg/dl twice.On (b)(6) 2025, the initial sample was retested on the cobas c311 analyzer, and the result was 1.158 mg/dl.The same initial sample was sent to another laboratory that uses an abbott analyzer, and the result was 0.52 mg/dl.
Additional Manufacturer Narrative
A general product issue could be excluded as calibration and quality control were within the specifications.The investigation did not identify a product problem.

• 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: 22087186
• Report Number: 1823260-2025-01612
• Device Sequence Number: 12768182
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 05589061190
• Device Lot Number: 80477201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/10/2025
• 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 Age: 2 MO
• Patient Sex: Male