BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 2983399 · Received February 28, 2013

    Report

    Report Number
    1415939-2013-00076
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08K25-25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08K25-27. (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 IT WAS IDENTIFIED THAT THE MANUFACTURE LOCATION WAS INCORRECTLY DOCUMENTED. A NEW MANUFACTURE REPORT NUMBER WAS GENERATED TO CORRECT THE MANUFACTURE LOCATION FIELDS. PLEASE REFER TO MANUFACTURE REPORT NUMBER 3002809144-2013-00064.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS FALSELY ELEVATED ARCHITECT INTACT PTH (IPTH) ASSAY RESULTS. ONE PATIENT GENERATED A RESULT OF 42.3 PG/ML. THE SAMPLE WAS THEN TESTED BY AN RIA METHODOLOGY AND GENERATED A RESULT OF 29.89 PG/ML. THE CUSTOMER IS CONCERNED THAT EVEN THOUGH THE ARCHITECT IPTH ASSAY HAS THE SAME REFERENCE RANGE AS THE RIA METHOD THAT THE ARCHITECT RESULTS HAVE SUCH A HIGH BIAS. THE CUSTOMER ALSO EXPRESSED CONCERN THAT EXTERNAL PROFICIENCY TEST RESULTS SHOW THAT THE ARCHITECT IPTH ASSAY IS NOT IN LINE WITH ANY COMPETITOR ASSAY AND DEMONSTRATES A VERY HIGH BIAS. NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85975 ARCHITECT IPTH CEW ABBOTT LABORATORIES 02112E000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR LN: 01L86-01| SN: (B)(4)| ARCHITECT I1000SR LN: 01L86-01| SN: (B)(4)