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

Catalog Number	08056960190
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received a questionable result for one patient sample tested with cobas c bilirubin total gen.3 with a cobas c 503 analytical unit.The customer noted that the sample appeared very dark, but there were no alarms indicating hemolysis, icterus, or lipemia.The sample initially resulted in a total bilirubin value of 0.491 mg/dl.The sample was repeated on a blood gas analyzer, resulting in a total bilirubin value of 1.98 mg/dl.The sample was also repeated using a competitor photometric method, resulting in a total bilirubin value of 1.85 mg/dl.This value aligned more closely with the clinical presentation of the patient.
Additional Manufacturer Narrative
The serial number of the c503 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The customer stated that controls were within range.The reaction kinetics data of the initial sample measurement were abnormal.An interference in the assay due to the drug eltrombopag can be ruled out.The investigation could not identify a product problem.The 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: 19633213
• Report Number: 1823260-2024-01876
• Device Sequence Number: 15594284
• Product Code: CIG
• UDI-Device Identifier: 07613336121078
• UDI-Public: 07613336121078
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• 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): 07/11/2024

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: 08056960190
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/11/2024
• 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: ELTROMBOPAG
• Patient Age: 10 YR
• Patient Sex: Unknown