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

Catalog Number	08056960190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable bilt3 bilirubin total gen.3 results for 1 patient sample on a cobas pro c 503 analytical unit compared to an abl90 blood gas analyzer.The customer initially questioned the result as it did not match the patient's clinical picture.The patient sample was brown in color and had a "jaundice index of 3." the patient's doctor did not see any signs of jaundice in the patient.The initial bilt3 result was 0.97 mg/dl.The sample was also run on an abl90 blood gas analyzer and the result was 2.8 mg/dl.A 1:2 and a 1:4 serial dilution were performed obtaining total bilirubin results of 0.9 mg/dl on the same cobas pro.A repeat total value of 0.944 mg/dl was also provided.Clarification was requested on if this result was obtained from a diluted sample was requested but not provided.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The qc and calibration recovery data provided was acceptable.Based on the calibration and qc data, a general reagent issue could be excluded.It was determined that the brown color of the patient's sample was caused by the medication eltrombopag.No interference from this drug has been found to effect the total and direct bilirubin assays.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: COBAS C 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: 17644860
• Report Number: 1823260-2023-02819
• Device Sequence Number: 18085010
• Product Code: CIG
• UDI-Device Identifier: 07613336121078
• UDI-Public: 07613336121078
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: K131544NA
• 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): 10/23/2023

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: 03/31/2024
• Device Catalogue Number: 08056960190
• Device Lot Number: 647036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/23/2023
• 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: Female