BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 2113845 · Received June 3, 2011

    Report

    Report Number
    3002809144-2011-00325
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION INTO THE CUSTOMER'S CURRENT ISSUE INCLUDED ACCURACY TESTING IN WHICH THREE ARCHITECT ANALYZERS WERE CALIBRATED SUCCESSFULLY FOLLOWED BY SIX REPLICATES OF EACH CONTROL LEVEL ACROSS THE ANALYZERS USING BOTH THE ROUTINE AND STAT MODES OF OPERATIONS. ALL GENERATED RESULTS MET ACCEPTANCE CRITERIA. DATA PROVIDED BY THE CUSTOMER WAS ALSO REVIEWED WITH NO ISSUES IDENTIFIED. 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 STUDY DOCUMENTED IN "PERFORMANCE CHARACTERISTICS OF SIX INTACT PARATHYROID HORMONE ASSAYS" - (B)(4), WAS REVIEWED. THE REVIEW INDICATED THAT WHILE THE ARCHITECT IPTH ASSAY SHOWED A POSITIVE BIAS, THE CORRELATION BETWEEN ALL SIX OF THE PLATFORMS TESTED WAS GOOD. THE ABBOTT ARCHITECT INTACT PTH PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE RESULTS OF THIS EVALUATION, THE ARCHITECT IPTH REAGENTS ARE PERFORMING AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. ARCHITECT IPTH ASSAY LN: 8K25-20 LOT: 01210F000. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8K25-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8K25-27. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ARCHITECT IPTH ASSAY GENERATES DISCREPANT RESULTS (USUALLY HIGH) WHEN COMPARED TO NON-ABBOTT METHODOLOGIES. THE CUSTOMER STATES THAT THIS IS OCCURRING WITH VARIOUS LOTS OF THE ARCHITECT IPTH ASSAY WITH BOTH SERUM AND PLASMA PATIENT SAMPLES. THE CUSTOMER GAVE THE EXAMPLE OF ONE PATIENT SAMPLE GENERATING AN ARCHITECT IPTH RESULT OF 24.0 PG/ML THAT TESTED AT 9.00 PG/ML WITH A NON-ABBOTT METHOD. 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 02310G000

    Patients

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