BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 CMV IGM

    MDR report key: 6053796 · Received October 25, 2016

    Report

    Report Number
    2432235-2016-00639
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    May 5, 2016
    Report Date
    October 25, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    LKQ
    PMA / PMN Number
    K100433
    Removal / Correction Number
    2432235-08/31/2016-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED INCREASED IMPRECISION ON SOME PATIENT SAMPLES WITH THE IMMULITE®/IMMULITE® 1000 CMV IGM REAGENT LOTS 330 AND 331 AND ON THE IMMULITE® 2000 / IMMULITE® 2000 LOTS 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 266, AND 267. THESE SAMPLES MAY EXHIBIT HIGHER PERCENT COEFFICIENT OF VARIATION (% CV) THAN THE PRECISION PERFORMANCE DATA PUBLISHED IN THE INSTRUCTIONS FOR USE (IFU) ACROSS NONREACTIVE, INDETERMINATE, AND REACTIVE RATIOS. QUALITY CONTROLS PROVIDED IN THE CMV IGM KIT MAY NOT DETECT THE IMPRECISION WITH PATIENT RESULTS. AN URGENT FIELD SAFETY NOTICE (UFSN) IMC 16-22A.OUS WAS SENT OUT TO CUSTOMERS AND AN URGENT MEDICAL DEVICE RECALL (UMDR) IMC16-22.A.US WAS SENT TO US CUSTOMERS IN AUGUST 2016. THE UFSN AND UMDR INFORMS THE CUSTOMERS TO DISCONTINUE USE OF AND DISCARD THE AFFECTED KIT LOTS LISTED ABOVE. SIEMENS RECOMMENDS TRANSITIONING TO IMMULITE 2000/2000 XPI CMV IGM KIT LOTS 268 AND ABOVE AND IMMULITE 1000 KIT LOT 332 AND ABOVE.

    Description of Event or Problem · 1

    THE CUSTOMER HAS INDICATED THAT THEY OBTAINED DISCORDANT IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) RESULT FOR ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT WHEN USING KIT LOT 263/264.THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). AS THE INITIAL RESULT WAS INDETERMINATE, THE CUSTOMER FOLLOWED THE IMMULITE 2000 XPI CMV IGM INSTRUCTIONS FOR USE BY OBTAINING A NEW SAMPLE FROM THE PATIENT TWO WEEKS LATER AND TESTING IT ON THE SAME INSTRUMENT. THE RESULT OBTAINED ON THE NEW SAMPLE WAS INDICATIVE OF SEROCONVERSION AND THE PATIENT WAS REPORTED TO HAVE A CURRENT CMV INFECTION. THE CUSTOMER REPEATED THE ORIGINAL SAMPLE TWICE ON THE SAME INSTRUMENT USING KIT LOT 268, WHICH RESULTED REACTIVE. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CMV IGM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707245 IMMULITE 2000 CMV IGM IMMULITE 2000 CMV IGM LKQ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 CMV IGM 263/264

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR