BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI HAV IGM REAGENT

    MDR report key: 3359664 · Received September 20, 2013

    Report

    Report Number
    3007111389-2013-00180
    Event Type
    Malfunction
    Date Received
    September 20, 2013
    Date of Event
    August 15, 2013
    Report Date
    September 20, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS DETERMINED THAT REPRODUCIBLE, DISCORDANT, REACTIVE VITROS (B)(6) RESULTS WERE OBTAINED ON TWO SEPARATE PATIENT SAMPLES TESTED ON A VITROS ECIQ SYSTEM. THE CUSTOMER CONCLUDED THE (B)(6) RESULTS TO BE (B)(6). THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, THE (B)(6) REAGENT LOT IN USE, THE VITROS ECIQ ANALYZER, OR THE SAMPLES INVOLVED IN THE EVENT CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THERE HAVE BEEN NO (B)(6) PATIENT RESULTS QUESTIONED BY THE PHYSICIANS, AND THERE ARE NO REPORTED ALLEGATIONS OF PATIENT HARM. A REVIEW OF THE OCD COMPLAINTS DATABASE FOUND NO OTHER COMPLAINTS OF THIS NATURE INVOLVING LOT 3460.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DISCORDANT, REACTIVE VITROS (B)(6) RESULTS WERE OBTAINED FROM TWO PATIENT SAMPLES COLLECTED FROM TWO DIFFERENT PATIENTS USING VITROS (B)(6) REAGENT, LOT 3460 ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM, COMPARED TO (B)(6) VITROS (B)(6) RESULTS OBTAINED FROM A NON-VITROS (B)(6) CENTAUR SYSTEM. BORDERLINE REACTIVE RESULTS: PATIENT 1: (B)(6) VALUE FROM CENTAUR (NO VALUE PROVIDED). PATIENT 2: (B)(6) VALUE FROM CENTAUR (NO VALUE PROVIDED). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULTS FOR PATIENTS 1 WAS REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, THE CUSTOMER INDICATED NO CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN. THE AFFECTED PATIENT RESULT FOR PATIENTS 2 WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474823 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI HAV IGM REAGENT IN-VITRO DIAGNOSTIC LOL ORTHO-CLINICAL DIAGNOSTICS 3460

    Patients

    Seq Age Sex Outcome Treatment
    1