BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 2102795 · Received May 25, 2011

    Report

    Report Number
    3002809144-2011-00319
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER (B)(4) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4). ARCHITECT IPTH LOT#: 02310G000.

    Additional Manufacturer Narrative · 1

    THE EVALUATION BEGAN BY TESTING ARCHITECT INTACT PTH REAGENT LOTS 00710K000 AND 02310G000. THREE ARCHITECT INSTRUMENTS WERE CALIBRATED, AND A SINGLE REPLICATE OF ABBOTT CONTROL (AS VALIDITY CHECKS) WAS TESTED. USING AN ACCEPTED CALIBRATION CURVE, SIX REPLICATES OF EACH CONTROL LEVEL WERE RUN ACROSS THE THREE INSTRUMENTS USING THE ROUTINE AND STAT MODES OF THE ASSAY. THIS TESTING MET ACCEPTANCE CRITERIA. IN ADDITION, A REVIEW WAS PERFORMED OF A STUDY THAT EVALUATED THE PERFORMANCE CHARACTERISTICS OF SIX INTACT PARATHYROID HORMONE (PTH) ASSAYS, INCLUDING THE ARCHITECT IPTH ASSAY. IT WAS DETERMINED THAT THE ARCHITECT IPTH ASSAY SHOWED A POSITIVE BIAS OF APPROXIMATELY 30% TO THE ROCHE E170 IPTH ASSAY, WHICH WAS THE METHOD USED TO COMPARE RESULTS. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT INTACT PTH PACKAGE INSERT (COMMODITY (B)(4)) CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE CURRENT EVALUATION, IT WAS DETERMINED THAT THE ARCHITECT INTACT PTH ASSAY IS PERFORMING AS INTENDED, AND IS MEETING ITS SAFETY, EFFECTIVENESS, AND LABEL CLAIMS. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT PATIENT RESULTS GENERATED BY THE ARCHITECH IPTH ASSAY ARE HIGHER THAN RESULTS FOR THE SAME PATIENT SAMPLES TESTED FOR PTH AT A REFERENCE LAB. THE CUSTOMER GAVE THE EXAMPLE OF AN ARCHITECT IPTH RESULT FOR ONE SAMPLE OF 86 PG/ML THAT TESTED AT 55 PG/ML AT THE REFERENCE LAB (B)(4). CONTROLS HAVE REMAINED WITHIN SPECIFICATIONS. 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
    1 ARCHITECT IPTH FOR THE DETERMINATION OF INTACT PARATHYROID HORMONE IN SERUM OR PLASMA CEW ABBOTT GERMANY 00710K000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH IPTH LN: 08K25-20 LOT: 02310G000| ARCH I2000SR LN: 3M74-95 SN: (B)(4)| ARCH I2000SR LN: 03M74-95 SN: (B)(4)