BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS BC REAGENT

    MDR report key: 3472413 · Received November 15, 2013

    Report

    Report Number
    1319809-2013-00266
    Event Type
    Malfunction
    Date Received
    November 15, 2013
    Date of Event
    October 16, 2013
    Report Date
    November 15, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN. THE DERIVED VITROS DBIL (CONJUGATED + DELTA BILIRUBIN) RESULT OF 1.8 MG/DL WAS CONCORDANT TO THE DADE DIRECT BILIRUBIN RESULT OF 1.7 MG/DL. IT IS POSSIBLE, BUT NOT CONFIRMED, THAT THE DIFFERENCE IN THE VITROS BC RESULT AND THE DADE DIRECT BILIRUBIN RESULT IS CAUSED BY DELTA BILIRUBIN BEING INCLUDED IN THE DADE DIRECT BILIRUBIN RESULT. THERE WAS NO INDICATION THE VITROS 350 CHEMISTRY SYSTEM OR THE VITROS BC MICROSLIDES MALFUNCTIONED. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A VITROS BC RESULT OF 0.4 MG/DL OBTAINED FROM A SINGLE PATIENT SAMPLE AS A DIRECT BILIRUBIN RESULT, AND WAS LOWER THAN EXPECTED WHEN COMPARED TO A DIRECT BILIRUBIN RESULT (1.7 MG/DL) OBTAINED FROM A NON-VTROS DADE ANALYZER. THE VITROS RESULT WAS PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE VITROS BC RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AS A DIRECT BILIRUBIN RESULT AND WAS LOWER THAN EXPECTED. TREATMENT WAS INITIATED BASED ON THE LOWER THAN EXPECTED DIRECT BILIRUBIN RESULT. THE PATIENT WAS GIVEN A LARGER DOSE OF ONE TYPE OF CHEMOTHERAPY DRUG AND WAS ALSO GIVEN A THIRD TYPE OF DRUG THAT WOULD NOT BE GIVEN TO A PATIENT WITH AN ELEVATED DIRECT BILIRUBIN VALUE. THE PATIENT EXPERIENCED NAUSEA AND VOMITING AFTER TREATMENT, AND IT IS UNKNOWN IF THE SYMPTOMS WERE CAUSED BY THE LARGER DOSE OF ONE DRUG AND THE INCLUSION OF THE OTHER DRUG, OR BY A GENERAL TOXICITY CAUSED BY THE CHEMOTHERAPY DRUGS. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593548 VITROS CHEMISTRY PRODUCTS BC REAGENT IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 0232-0362-4300

    Patients

    Seq Age Sex Outcome Treatment
    1