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	04/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable bilt3 bilirubin total gen.3 results for 1 patient on a cobas 6000 c501 module compared to a radiometer blood gas analyzer.The doctor questioned the low roche results compared to the blood gas analyzer results as they do not match the patient's clinical picture.The patient had the following bilt3 serum sample results from the c501 module: on (b)(6) 2024 the result was 1.41 mg/dl.On (b)(6) 2024 the result was 1.04 mg/dl.On (b)(6) 2024 the result was 0.69 mg/dl.On (b)(6) 2024 the result was 0.57 mg/dl.The patient had the following capillary sample results from the blood gas analyzer: on (b)(6) 2024 the result was 4.7 mg/dl.On (b)(6) 2024 the result was 3.9 mg/dl.On (b)(6) 2024 the result was 3.0 mg/dl.On (b)(6) 2024 the result was 3.1 mg/dl.Clarification on if the capillary sample was collected at the same time as the serum sample was requested.The roche reference range is <1.2 mg/dl for adults.The radiometer reference range is <2 mg/dl for adults.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 19273484
• Report Number: 1823260-2024-01391
• Device Sequence Number: 20598462
• 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): 07/15/2024

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 Expiration Date: 05/31/2025
• Device Catalogue Number: 05795397190
• Device Lot Number: 75672301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 07/15/2024
• 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: ANTI-HUMAN-T-LYMPHOZYTEN-IMMUNGLOBULIN
• Patient Sex: Unknown