BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 2881931 · Received December 20, 2012

    Report

    Report Number
    3002809144-2012-00172
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    December 9, 2012
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, ACCURACY TESTING, A STUDY REVIEW, REVIEW OF RELEASE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. ACCURACY TESTING WAS COMPLETED AND PASSED. A STUDY TITLED, "(B)(4)" WAS REVIEWED WHICH INDICATES ARCHITECT IPTH CORRELATES WELL AGAINST THE ROCHE MODULE E170. A REVIEW OF RELEASE TESTING SHOWED NO SHIFT. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I1000SR ANALYZER GENERATED A FALSELY ELEVATED IPTH RESULT FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED AN IPTH RESULT OF 150.5. THE SAMPLE WAS REPEATED AT A REFERENCE LABORATORY (METHOD UNKNOWN) AND RESULTS OF 77.4 AND 73.2 WERE GENERATED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT IPTH CEW ABBOTT GERMANY 03112E000

    Patients

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