BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 CMV IGM

    MDR report key: 5937710 · Received September 8, 2016

    Report

    Report Number
    2432235-2016-00518
    Event Type
    Malfunction
    Date Received
    September 8, 2016
    Date of Event
    April 12, 2016
    Report Date
    September 8, 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
    EC
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 A DISCORDANT, FALSE REACTIVE IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) RESULT FOR ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT WHEN USING KIT LOT 260. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING NON-REACTIVE. IT IS UNKNOWN IF THE NON-REACTIVE RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE REACTIVE CMV IGM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586958 IMMULITE 2000 CMV IGM IMMULITE 2000 CMV IGM LKQ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 CMV IGM 260

    Patients

    Seq Age Sex Outcome Treatment
    1