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

Catalog Number	05795419190
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bilt3 reagent expiration date was not provided.The c701 module serial number was (b)(6).Qc was acceptable on the day of the event.The investigation is ongoing.
Event or Problem Description
We received an allegation about a suspected drug interference for 1 patient serum sample tested with bil-t gen.3 (bilt3) assay on a cobas 8000 cobas c701 module.The customer mentioned that the sample was abnormally dark in color and they were concerned that the dark color of the serum might be interfering with the test.The bilt3 result was 10.2.The unit of measurement was not provided.The result was reported outside the laboratory and the sample was not repeated.The customer also mentioned that the serum index (si) was normal: hemolysis: 20.Icterus: 4.Lipemia: 49.
Additional Manufacturer Narrative
Concomitant medical product section and section b6 were updated.The customer alleged additional test results for the same patient tested on (b)(6) 2024: bilt3 result: 8.4.The unit of measurement was not provided.The serum index (si) results were as follows: hemolysis: 21 icterus: 4 lipemia: 56.The medication eltrombopag is known to cause the dark coloration of the sample.The investigation studied eltrombopag interference and determined no interference was found for the tested roche assays.The investigation did not identify a product problem.The cause of the event was due to a patient sample-related 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19820342
• Report Number: 1823260-2024-02149
• Device Sequence Number: 15624244
• Product Code: CIG
• UDI-Device Identifier: 04015630928903
• UDI-Public: 04015630928903
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 08/29/2024

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: 05795419190
• Device Lot Number: ASKU
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/29/2024
• 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: AROMASINE; AROMASINE 25MG IN THE MORNING; KISQALI; REVOLAB (REVOLADE); REVOLADE 75MG 3 TABLETS/EVENING SINCE SUMMER 2023
• Patient Sex: Female