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

Model Number	BIL-T G3
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with bilt3 bilirubin total gen.3 on cobas 8000 c (701) module serial number (b)(6) , a cobas 6000 c (501) module (serial number unknown), and an unknown roche analyzer (serial number unknown).The patient sample was noted to be brown in color and the reporter alleges it may contain an interfering factor against a component of the total bilirubin assay.The reporter also noted that the same issue has occurred with this patient before.The plasma tube of the patient sample initially resulted in a total bilirubin value of 0.7 mg/dl when tested on the c 701 analyzer.The questionable result was reported outside of the laboratory.The plasma and serum tubes of the patient sample were repeated on the c 501 analyzer and all total bilirubin results were 0.7 mg/dl.The serum sample was then sent to a second site where it was tested on an unknown roche analyzer, resulting in a total bilirubin value of 0.7 mg/dl.The serum sample was sent to a third site where it was tested on a beckman coulter au680 analyzer, resulting in a total bilirubin value of 3.6 mg/dl.The serum sample was also sent to a fourth site where it was tested using an unknown method, resulting in a total bilirubin value of 3.7 mg/dl.The repeat value was deemed correct.
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.The patient was taking the drug promacta (eltrombopag).Investigation measurements were performed where the highest eltrombopag concentration under therapeutic treatment was used with 80 mol/l (100 mol/l according to clsi ep37 (b)(6) 2018 ).No interference was found against the total bilirubin assay.The observed discrepant results could be explained by the administration of more than 80 mol/l eltrombopag.The affected samples were not protected from the light and were also not frozen at - 20 degrees celcius.
Additional Manufacturer Narrative
Original sentence: investigation measurements were performed where the highest eltrombopag concentration under therapeutic treatment was used with 80 mol/l (100 mol/l according to clsi ep37 4/2018).Corrected sentence: investigation measurements were performed where the highest eltrombopag concentration under therapeutic treatment was used with 80 g/ml (100 g/ml according to clsi ep37 4/2018).

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16797144
• Report Number: 1823260-2023-01377
• Device Sequence Number: 3252152
• Product Code: CIG
• UDI-Device Identifier: 04015630928903
• UDI-Public: 04015630928903
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 10/18/2023

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: 05/31/2024
• Device Model Number: BIL-T G3
• Device Catalogue Number: 05795419190
• Device Lot Number: 66083101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 10/15/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 07/24/2023; 10/18/2023
• 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: CEFDINIR.; CYCLOSPORINE.; FLUCONAZOLE.; PANTOPRAZOLE.; PROMACTA.; VALACYCLOVIR.
• Patient Age: 65 YR
• Patient Sex: Male