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

Catalog Number	05795397190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bilt3 reagent expiration date was not provided.The c502 module serial number was (b)(6).Calibration and qc were acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about questionable low results for 1 patient sample tested with bilirubin total gen.3 (bilt3) assay on a cobas 8000 cobas c502 module not matching the patient's clinical examination.The patient had several bilt3 results ranging between 0.24 mg/dl and 0.34 mg/dl and were considered within the normal range of a healthy person.The patient was tested in another laboratory with a competitor's (abbott architect) method resulting in a bilirubin value of 0.2 mg/dl which was also considered within the normal range.The patient had a sonographic and radiological examination of an enlargement of both the intrahepatic and the extrahepatic bile duct system in the sense that a bile reflux was detected.The bilt3 results were reported outside the laboratory and the customer questioned whether the bilt3 results could be used to diagnose bile reflux.
Additional Manufacturer Narrative
According to the information alleged by the customer and as set out in the medical opinion based on literature reports and common clinical practice, there is no evidence of contradiction between the reported radiological findings and the obtained bilirubin results within the normal range of expected values (even confirmed by competitor results).The investigation did not identify a product problem.The root cause was due to the patient's condition.

• 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: 19372302
• Report Number: 1823260-2024-01526
• Device Sequence Number: 7689223
• Product Code: CIG
• UDI-Device Identifier: 04015630928897
• UDI-Public: 04015630928897
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 07/31/2024

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 07/31/2024
• 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
• Patient Sex: Unknown