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

Catalog Number	05795397190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bilt3 reagent expiration date was not provided.The c501 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with bilirubin total gen.3 (bilt3) assay on a cobas 6000 c501 module.Sample 1: initial result: 71.6 umol/l.The sample was repeated and the repeat results were 8.5 umol/l, 43.7 umol/l, 12.7 umol/l, and 18.7 umol/l.On (b)(6)2025, a new sample (sample 2) was drawn and tested.Initial result: 6.6 umol/l.The serum sample was repeated and the repeat results were 10.2 umol/l and 27.7 umol/l.The plasma sample was repeated and the repeat results were 11.1 umol/l and 8.9 umol/l.The customer suspected an interference.
Additional Manufacturer Narrative
General reagent and instrument issues can be excluded as the calibration and the qc were acceptable.The investigation did not identify a product problem.The cause of the event was related to the samples of this specific patient: the patient was severely sick with bladder cancer and received numerous medications.Some of the medications are known to affect liver function/bilirubin values on a physiological level.The observed effects on bilirubin were not related to an analytical interference, but rather to a physiological response of the patient to the medications.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21431931
• Report Number: 1823260-2025-00503
• Device Sequence Number: 4606135
• Product Code: CIG
• UDI-Device Identifier: 04015630928897
• UDI-Public: 04015630928897
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 03/24/2025

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 Catalogue Number: 05795397190
• Device Lot Number: 791656
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AGNEOUR MORPHINE; CYMBALTA 6 MG; FLUCONAZOLE; IM VITAMIN B12; IV ADANMEL; IV DEXAMETHASONE; IV DIPOPTIVAN; IV ERTAPENEM (INVANZ); IV HUMAN ALBUMIN; IV MAXOLON; IV PERM; IV SOLUVIT; IV SULPERAZON; IV VITALIPID; KIDDIE PHARMATON; NEXIUM; T. GANASTON; T. KEPAIRIL; T.M ETOSPOSPHYL; TORPEZIL 10 MG
• Patient Sex: Unknown