MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BILT3; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	05795397190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 2 patient's samples tested with bilirubin total gen.3 (bilt3) assay on a cobas 6000 c501 analyzer when compared to a non-roche (beckman coulter (b)(6) analyzer.Refer to the attachment for all patient data.No questionable results were reported outside the laboratory.The repeat results obtained by the non-roche analyzer were deemed to be correct.
Additional Manufacturer Narrative
The bilt3 reagent expiration date was not provided.The cobas 6000 c501 module serial number was (b)(6).Calibration and qc were acceptable.The field service engineer checked the gear pump pressure and it was within range.He also did a photometer check and the lamp was changed according to the recommendations.The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent issue can be excluded since calibration and qc data were acceptable.The reagent manufacturers use different protocols for the standardization of their assays.Therefore, direct bilirubin results of different manufacturers are not directly comparable.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: BILT3
• 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: 18697129
• Report Number: 1823260-2024-00421
• Device Sequence Number: 7271009
• Product Code: CIG
• UDI-Device Identifier: 04015630928897
• UDI-Public: 04015630928897
• Combination Product (Y/N): Y
• Initial Reporter Country: RO
• 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): 05/07/2024

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: 05795397190
• Device Lot Number: 717509
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown