BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 3604666 · Received February 3, 2014

    Report

    Report Number
    3002809144-2014-00015
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Report Date
    January 13, 2014
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST 8K25-25, THAT HAS A SIMILAR US PRODUCT DISTRIBUTED IN THE US, LIST 8K25-27. (B)(4). A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED FALSELY ELEVATED ARCHITECT IPTH ON PATIENT SAMPLES THAT TESTED 50% LOWER BY ANOTHER METHOD. EXAMPLES WERE PROVIDED FOR 11 PATIENTS. NO UNIT OF MEASURE WAS PROVIDED. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. DATA PROVIDED: ROCHE METHOD = 31.4, ARCHITECT IPTH = 59.2, ID (B)(4), ROCHE METHOD = 37.1, ARCHITECT IPTH = 64.2, ID (B)(4), ROCHE METHOD = 54.3, ARCHITECT IPTH = 89.0, ID (B)(4), ROCHE METHOD = 52.4, ARCHITECT IPTH= 103.1, ID (B)(4), ROCHE METHOD = 30.3, ARCHITECT IPTH= 55.3, ID (B)(4), ROCHE METHOD = 29.4, ARCHITECT IPTH= 45.9, ID (B)(4), ROCHE METHOD = 33.1, ARCHITECT IPTH = 64.8, ID (B)(4), ROCHE METHOD = 81.8, ARCHITECT IPTH = 151.6, ID (B)(4), ROCHE METHOD = 75.7, ARCHITECT IPTH = 139, ID (B)(4), ROCHE METHOD = 35.3, ARCHITECT IPTH = 67.2, ID (B)(4), ROCHE METHOD = 17.5, ARCHITECT IPTH = 28.0, ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70313 ARCHITECT IPTH CEW ABBOTT GERMANY 01113C000

    Patients

    Seq Age Sex Outcome Treatment
    1 SERIAL (B)(4)| ARCHITECT I1000SR, LIST 01L86-01