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

Catalog Number	05795397190
Medical Device Problem Codes	Low Test Results (2458); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c502 module serial number was (b)(6).
Event or Problem Description
The initial reporter questioned low results not corresponding to the clinical picture for 2 patient samples tested for bilt3 on a cobas 8000 c 502 module.An example was provided for 1 patient sample.The bilt3 result was 0.9 mg/dl.The serum index results were normal but the sample appeared brown/green.The customer did not repeat the sample on the c502 module as they did not believe the result would be correct.
Additional Manufacturer Narrative
Section d10 was updated.
Additional Manufacturer Narrative
Section b7 was updated.
Additional Manufacturer Narrative
The patient sample was not available for investigation.Calibration was last performed on (b)(6) 2024 with acceptable results.Incomplete qc information was provided.The sample was spun down for 10 minutes at 4150 revolutions per minute (rpm).This spin speed may be faster than recommended.During a review of the alarm trace data, "abnormal aspiration" and sample probe errors were observed.These alarms are indicators of possible poor sample quality.The field application specialist (fas) stated the issue was due to the patient sample.The patient was taking 75 mg of eltrombopag per day.According to the manufacturer of eltrombopag, the medication is "highly coloured and so has the potential to interfere with some laboratory tests.".As the sample is no longer available for investigation, the specific root cause could not be determined.The investigation did not identify a product problem.

• 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: 18948325
• Report Number: 1823260-2024-00840
• Device Sequence Number: 15466798
• Product Code: CIG
• UDI-Device Identifier: 04015630928897
• UDI-Public: 04015630928897
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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 Expiration Date: 02/28/2025
• Device Catalogue Number: 05795397190
• Device Lot Number: 743011
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 03/25/2024; 06/01/2024; 07/09/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/12/2024; 06/18/2024; 07/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN; ELTROMBOPAG; ELTROMBOPAG - 75 MG 1X/DAY; FLOWMAX; LEXAPRO; MORPHINE; NARCAN; PROTONIX; QUESTRAN; SYNTHROID; TYLENOL; ZOFRAN
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 74 KG