BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI HAV IGM REAGENT PACK

    MDR report key: 6166092 · Received December 12, 2016

    Report

    Report Number
    3007111389-2016-00237
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 16, 2016
    Report Date
    December 12, 2016
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS DETERMINED THAT REPRODUCIBLE, DISCORDANT, REACTIVE VITROS ANTI HAV IGM RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE USING TWO DIFFERENT VITROS ANTI HAV IGM REAGENT LOT ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. THE DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. BASED ON AVAILABLE HISTORICAL QUALITY CONTROL RESULTS, A VITROS ANTI-HAV IGM PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. VITROS TROPI ES PRECISION TESTING PERFORMED ON THE VITROS 5600 INTEGRATED SYSTEM (J1) WAS WITHIN ACCEPTABLE GUIDELINES, SUGGESTING AN INSTRUMENT ISSUE WAS NOT LIKELY A CONTRIBUTING FACTOR. NO PRECISION TESTING WAS PERFORMED ON VITROS 5600 INTEGRATED SYSTEM (J2), BUT AS BOTH INSTRUMENTS INDEPENDENTLY PRODUCED DISCORDANT REACTIVE RESULTS, AN INSTRUMENT ISSUE IS UNLIKELY TO BE THE CAUSE OF THIS ISSUE. IN ADDITION, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS NOT POSSIBLE TO ESTABLISH IF THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE¿S RECOMMENDATION FOR SAMPLE CENTRIFUGATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. FURTHERMORE, THE PRESENCE OF AN UNKNOWN SAMPLE INTERFERENT OR METHOD TO METHOD DIFFERENCE CANNOT BE COMPLETELY RULED OUT AS THE CAUSE OF THE DISCORDANT REACTIVE RESULTS THE DEFINITIVE ASSIGNABLE CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED UNEXPECTED REACTIVE VITROS ANTI-HAV IGM RESULTS FROM A SINGLE PATIENT SAMPLE USING TWO DIFFERENT VITROS ANTI-HAV IGM REAGENT LOTS RUN ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. THE REACTIVE VITROS ANTI-HAV IGM RESULTS WERE CONSIDERED TO BE UNEXPECTED BASED ON A NEGATIVE ANTI-HAV IGM RESULT OBTAINED FROM AN ALTERNATE SAMPLE COLLECTED FROM THE SAME PATIENT THAT WAS TESTED ON A NON-VITROS ROCHE SYSTEM. (B)(4). VITROS ANTI-HAV IGM REAGENT LOT 4580. VITROS ANTI-HAV IGM RESULT OF 1.58 S/C VS. AN EXPECTED NEGATIVE RESULT. (B)(4). VITROS ANTI-HAV IGM REAGENT LOT 4638. VITROS ANTI-HAV IGM RESULT OF 1.77 S/C VS. AN EXPECTED NEGATIVE RESULT. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE UNEXPECTED REACTIVE VITROS ANTI-HAV IGM RESULT WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO 3500A FORMS FILED FOR THIS EVENT, AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818606 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI HAV IGM REAGENT PACK IN-VITRO DIAGNOSTIC LOL ORTHO-CLINICAL DIAGNOSTICS 4580

    Patients

    Seq Age Sex Outcome Treatment
    1