MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BILIRUBIN TOTAL GEN.3; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	05795397190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable bilirubin total gen.3 results from the cobas 4000 c311 stand alone system.At 11:24 am, the initial serum bilirubin result was 345.1 mol/l.At 4:30 pm, the infant was evaluated at another hospital, where a new blood sample was collected.The bilirubin result was 228 mol/l.Two days later, the repeat bilirubin result was 188 mol/l.It was unclear if this result was generated from one of the these samples or from a newly collected sample.
Additional Manufacturer Narrative
The cobas 4000 c311 stand alone system serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Clarification was received that the repeat bilirubin result of 188 ¿mol/l obtained two days later was from a new sample from a new blood collection.The field application specialist was provided information stating the issue was due to a miscommunication at the customer site, in which the value was misheard when conveyed by the doctor to the laboratory department.The error was later corrected, and the revised results were consistent with the patient¿s clinical condition.The investigation did not identify any product issue.

• Brand Name: BILIRUBIN TOTAL GEN.3
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• 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: 23802333
• Report Number: 1823260-2025-05109
• Device Sequence Number: 18069398
• Product Code: CIG
• UDI-Device Identifier: 04015630928897
• UDI-Public: 04015630928897
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: K131544
• 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): 02/19/2026

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: 04/30/2026
• Device Catalogue Number: 05795397190
• Device Lot Number: 82297301
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/19/2026
• 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: 16 DA
• Patient Sex: Unknown