BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 1007549 · Received March 4, 2008

    Report

    Report Number
    1319808-2008-00062
    Event Type
    Malfunction
    Date Received
    March 4, 2008
    Date of Event
    February 3, 2008
    Report Date
    February 6, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT FOUND THAT THE REAGENT PACK THE USER WAS USING WAS GIVING POSITIVELY BIASED RESULTS. THE REAGENT LOT IN QUESTION HAD RECENTLY BEEN RECEIVED AND CALIBRATED BY THE LABORATORY. THE USER HAD FIRST CALIBRATED THE REAGENT IN 2008, AND POST CALIBRATION RESULTS WERE ELEVATED AND OUTSIDE OF ACCEPTABLE LIMITS. THE USER DISCARDED THE SUSPECT REAGENT PACK AND SUCCESSFULLY CALIBRATED ANOTHER PACK FROM THE SAME LOT. ON TWO DAYS LATER, THE CUSTOMER AGAIN RECOVERED QC RESULTS OUTSIDE OF ACCEPTABLE RANGES. THE CUSTOMER REMOVED THE PACK AND REPLACED IT WITH AN ALTERNATE LOT WHICH GAVE ACCEPTABLE QC RESULTS. REPEAT OF THREE PATIENT SAMPLES THAT HAD BEEN RUN WITH THE SUSPECT LOT/REAGENT PACK GAVE SIGNIFICANTLY LOWER RESULTS WITH THE ALTERNATE LOT AND WERE DEEMED BY THE LABORATORY TO BE CORRECT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS INCIDENT. THE ROOT CAUSE OF THE EVENT IS UNDETERMINED, BUT THE INVESTIGATION HAS CONCLUDED THAT THE SUSPECT PRODUCT WAS MOST LIKELY COMPROMISED DURING SHIPPING. THE CUSTOMER WAS SENT REPLACEMENT PRODUCT OF THE SAME LOT AS THE SUSPECT PRODUCT AND IT HAS PERFORMED ACCEPTABLY.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED QC AND PATIENT RESULTS USING VITROS VANC REAGENT ON A VITROS 5,1 FS CHEMISTRY ANALYZER. PT RESULTS WERE REPORTED DURING THE TIME OF THE EVENT; HOWEVER, THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN VITRO DEVICE LEH ORTHO-CLINICAL DIAGNOSTICS NA 1514-08-7983

    Patients

    Seq Age Sex Outcome Treatment
    1