BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI HAV IGM REAGENT PACK

    MDR report key: 6401084 · Received March 13, 2017

    Report

    Report Number
    3007111389-2017-00029
    Event Type
    Malfunction
    Date Received
    March 13, 2017
    Date of Event
    February 10, 2017
    Report Date
    March 13, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DISCORDANT (B)(6) RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED USING VITROS (B)(6) REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED, HOWEVER, SAMPLE RELATED ISSUES CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THE PATIENT 1 SAMPLE WAS INITIALLY COLLECTED APPROXIMATELY 2 YEARS AGO, WAS SEPARATED INTO ALIQUOTS AND STORED FROZEN. IT IS POSSIBLE THAT DEGRADATION OF THE (B)(6) ANTIBODY IN THE SAMPLE OCCURRED DURING THE 2 YEAR TIMEFRAME, ALTHOUGH THIS COULD NOT BE CONFIRMED. ORTHO DOES NOT MAKE ANY CLAIMS CONCERNING THE STABILITY OF A SAMPLE ONCE IT IS PUT INTO FROZEN STORAGE. THE PATIENT 4 SAMPLE WAS INITIALLY COLLECTED AND TESTED APPROXIMATELY 6 MONTHS AGO, AND HAD BEEN STORED FROZEN SINCE THE INITIAL TEST EVENT. THE PATIENT 4 SAMPLE HAD BEEN THROUGH 4 ¿ 5 FREEZE/THAW CYCLES IN THAT 6 MONTH TIMEFRAME, AND IT IS LIKELY THAT DEGRADATION OF THE (B)(6) ANTIBODY IN THE SAMPLE OCCURRED. THERE WAS NO INDICATION OF A VITROS (B)(6) REAGENT LOT PERFORMANCE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO DISCORDANT NEGATIVE VITROS (B)(6) RESULTS OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES USING A VITROS 5600 INTEGRATED SYSTEM WHEN COMPARED TO HISTORICAL VITROS (B)(6) RESULTS FROM THE SAME PATIENTS USING DIFFERENT VITROS (B)(6) REAGENT LOTS. PATIENT 1 = (B)(6) (0.08 S/C) VERSUS EXPECTED (B)(6) (1.39 S/C), PATIENT 4 = (B)(6) (0.06 S/C) VERSUS EXPECTED (B)(6) (3.56 S/C). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE DISCORDANT NEGATIVE VITROS ANTI HAV IGM RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER 2 OF 2 MDR¿S FOR THIS EVENT. TWO (2) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 2 DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183442 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI HAV IGM REAGENT PACK IN-VITRO DIAGNOSTICS LOL ORTHO-CLINICAL DIAGNOSTICS 4730

    Patients

    Seq Age Sex Outcome Treatment
    1