BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI RUBELLA IGM

    MDR report key: 5921014 · Received September 1, 2016

    Report

    Report Number
    2432235-2016-00443
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    June 1, 2016
    Report Date
    September 1, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    LFX
    PMA / PMN Number
    K012077
    Removal / Correction Number
    2432235-08/25/2016-002-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 THE RUBELLA IGM REAGENT LOTS D236M, D238, 236M, 237, 238, 239, AND 239L ON THE IMMULITE 2000/IMMULITE 2000 XPI SYSTEMS AND REAGENT LOTS 333, AND 334 ON THE IMMULITE/IMMULITE 1000 SYSTEMS EXHIBIT INCREASED IMPRECISION ON PATIENT SAMPLES. SIEMENS INTERNAL INVESTIGATION DEMONSTRATE THAT SOME PATIENT SAMPLES EXHIBIT HIGHER PERCENT COEFFICIENT OF VARIATION (%CV) THAN THE PRECISION PERFORMANCE PUBLISHED IN THE INSTRUCTIONS FOR USE (IFU) FOR THIS ASSAY. QUALITY CONTROLS PROVIDED IN THE RUBELLA IGM KIT MAY NOT DETECT THE IMPRECISION WITH PATIENT RESULTS. AN URGENT FIELD SAFETY NOTICE (UFSN) IMC16-20.A.OUS WAS SENT TO OUS CUSTOMERS AND A URGENT MEDICAL DEVICE RECALL (UMDR) IMC16-20.A.US WAS SENT TO US CUSTOMERS IN AUGUST OF 2016. THE UFSN AND UMDR STATE THAT CUSTOMERS ARE TO DISCONTINUE AND DISCARD THE KITS LOTS AFFECTED, AND TO REQUEST A REPLACEMENT LOT. SIEMENS RECOMMENDS TRANSITIONING TO IMMULITE/1000 RUBELLA IGM KIT LOT 0337 AND ABOVE OR TO IMMULITE 2000/2000 XPI RUBELLA IGM KIT LOT 240 AND ABOVE.

    Description of Event or Problem · 1

    DISCORDANT, FALSE REACTIVE RUBELLA IGM RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING REAGENT LOT 238. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). SAMPLE ID (B)(6) WAS REPEATED ON THE SAME INSTRUMENT, RESULTING NON-REACTIVE. BOTH SAMPLES WERE REPEATED ON AN ALTERNATE PLATFORM, RESULTING NON-REACTIVE. IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE REACTIVE RUBELLA IGM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571855 IMMULITE 2000 XPI RUBELLA IGM IMMULITE 2000 XPI RUBELLA IGM LFX SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI RUBELLA IGM 238

    Patients

    Seq Age Sex Outcome Treatment
    1