BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 INTACT PTH

    MDR report key: 6152100 · Received December 7, 2016

    Report

    Report Number
    2432235-2016-00713
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    July 11, 2016
    Report Date
    December 7, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    CEW
    PMA / PMN Number
    K013566
    Removal / Correction Number
    2432235-11/30/2016-004-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS IS CONDUCTING A RECALL FOR THE IMMULITE® 2000/IMMULITE® 2000 XPI INTACT PTH (INTACT PARATHYROID HORMONE) (IPTH) ASSAY KIT LOT 320. SIEMENS HAS CONFIRMED THAT IMMULITE® 2000/IMMULITE® 2000XPI INTACT PTH KIT LOT 320 CAN EXHIBIT AN AVERAGE NEGATIVE BIAS OF UP TO -39% AT IPTH CONCENTRATIONS <20 PG/ML WITH SERUM AND EDTA PATIENT SAMPLES VS. A REFERENCE KIT LOT. AN URGENT FIELD SAFETY NOTICE (UFSN) IMC 16-27.A.OUS WAS SENT TO OUS CUSTOMERS AND AN URGENT MEDICAL DEVICE RECALL (UMDR) IMC16-27.A.US WAS SENT TO US CUSTOMERS IN NOVEMBER 2016. THE UFSN AND UMDR INFORMS THE CUSTOMERS TO DISCONTINUE USE OF AND DISCARD THE AFFECTED KIT LOT. SIEMENS RECOMMENDS TRANSITIONING TO IMMULITE 2000/IMMULITE2000 XPI IPTH KIT LOTS 321 AND ABOVE. IMMULITE/IMMULITE 1000 IPTH IS NOT AFFECTED. SIEMENS IS CURRENTLY INVESTIGATING THE ROOT CAUSE OF THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED DISCORDANT, FALSELY LOW INTACT PARATHYROID HORMONE (IPTH) RESULTS ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING KIT LOT 320. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 INSTRUMENT USING KIT LOT 319, WHICH RESULTED HIGHER. IT IS UNKNOWN IF THE REPEAT RESULTS OBTAINED BY USING KIT LOT 319 WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW IPTH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804308 IMMULITE 2000 INTACT PTH IMMULITE 2000 INTACT PTH CEW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 INTACT PTH 320

    Patients

    Seq Age Sex Outcome Treatment
    1