BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 QUANTITATIVE CYTOMEGALOVIRUS IGG

    MDR report key: 3864070 · Received June 10, 2014

    Report

    Report Number
    2432235-2014-00366
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LGD
    PMA / PMN Number
    K993952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST EVALUATED THE CUSTOMER DATA. HSC CONTACTED THE CUSTOMER SITE AND REQUESTED THE SAMPLE TO BE SENT FOR IN-HOUSE TESTING AND INVESTIGATION. THE CAUSE OF THE FALSE NEGATIVE CMV IGG RESULT ON THE PATIENT SAMPLE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBTAINED A FALSE NEGATIVE RESULT ON ONE PATIENT SAMPLE FOR THE CYTOMEGALOVIRU (CMV) IGG ASSAY ON AN IMMULITE 2000 XPI INSTRUMENT, WHEN USING REAGENT LOT 291. THE SAME PATIENT SAMPLE WAS TESTED TWO MORE TIMES A MONTH LATER USING REAGENT LOT 292 AND THE RESULTS WERE POSITIVE. A NEW BLOOD DRAW WAS OBTAINED FROM THE PATIENT AND THE SAMPLE WAS TESTED TWO TIMES USING REAGENT LOT 292 AND THE RESULTS WERE POSITIVE. THE SAMPLE WAS THEN TESTED ON AN ALTERNATE PLATFORM AND THE RESULT WAS POSITIVE. THE INITIAL FALSE NEGATIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE POSITIVE RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE RESULT FROM THE ALTERNATE PLATFORM WAS RELEASED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE NEGATIVE RESULT ON THE ONE PATIENT SAMPLE FOR THE CMV IGG ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337677 IMMULITE 2000 QUANTITATIVE CYTOMEGALOVIRUS IGG IMMULITE 2000 QUANTITATIVE TOXOPLASMA IGG LGD SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 QUANTITATIVE CYTOMEGALOVIRUS IGG 291, 292

    Patients

    Seq Age Sex Outcome Treatment
    1