BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 3591741 · Received January 24, 2014

    Report

    Report Number
    3002809144-2014-00012
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    January 2, 2013
    Report Date
    January 9, 2014
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED RESULTS FROM (B)(4) PATIENT SAMPLES TESTED WITH THE ARCHITECT METHOD VERSES THE ROCHE METHOD. THE RESULTS ARE LISTED BELOW: COLLECTED-DATE: (B)(6) 2013, ARCHITECT: 64, ROCHE: 43; (B)(6) 2013, 314, 180; (B)(6) 2014, 116, 56; (B)(6) 2013, 119, 43; (B)(6) 2013, 83, 7; 2013, 684, 300; 2013, 30, 14; 2013, 17,8 89; (TEST RESULT). (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE EVALUATION RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT PATIENT RESULTS FOR THE ARCHITECT IPTH ASSAY ARE BEING QUESTIONED BY PHYSICIANS SINCE THEY ARE HIGHER THAN EXPECTED. SEVERAL PATIENT SAMPLES WERE SPLIT BY THE DOCTORS AND SENT OUT TO BE TESTED BY A DIFFERENT METHOD. THE RESULTS WERE LESS THAN THE ARCHITECT RESULTS BY APPROXIMATELY 50% SHIFT. ONE PATIENT SAMPLE GENERATED A RESULT OF 119 (UNIT OF MEASURE WAS NOT PROVIDED) BY THE ARCHITECT AND A RESULT OF 43 WAS GENERATED BY THE ROCHET METHOD. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56449 ARCHITECT IPTH CEW ABBOTT GERMANY

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2K 03M74-01 SN (B)(4)