BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HAV IGM REAGENT

    MDR report key: 2369939 · Received December 13, 2011

    Report

    Report Number
    3007111389-2011-00241
    Event Type
    Malfunction
    Date Received
    December 13, 2011
    Date of Event
    July 13, 2011
    Report Date
    December 13, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DISCORDANT (B)(6) VITROS ANTI-HAV IGM RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THERE WAS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT OR REAGENT MALFUNCTION OCCURRED. ADDITIONAL DISCORDANT (B)(6) VITROS ANTI-HAV IGM RESULTS ((B)(6)) WERE OBTAINED FROM THE SAME PATIENT SAMPLE USING AN ALTERNATE REAGENT LOT (2730) DURING INTERNAL TESTING PERFORMED BY OCD. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE PRESENCE OF AN UNKNOWN SAMPLE INTERFERENT COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED DISCORDANT (B)(6) VITROS ANTI-HAV IGM RESULTS ((B)(6)) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE (B)(6) VITROS ANTI-HAV IGM RESULTS WERE CONSIDERED TO BE (B)(6) BASED ON (B)(6) RESULTS OBTAINED FROM THE SAME PATIENT SAMPLE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE DISCORDANT (B)(6) VITROS ANTI-HAV IGM RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HAV IGM REAGENT IN-VITRO DIAGNOSTIC LOL ORTHO-CLINICAL DIAGNOSTICS 2720

    Patients

    Seq Age Sex Outcome Treatment
    1