BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 2220363 · Received August 23, 2011

    Report

    Report Number
    3002809144-2011-00555
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Report Date
    August 18, 2011
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCURACY TESTING WAS PERFORMED USING AN IN-HOUSE RESERVED SAMPLE. TESTING MET ALL VALIDITY AND ACCEPTANCE CRITERIA. 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 ABBOTT ARCHITECT INTACT PTH PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. A REVIEW OF THE FOLLOWING STUDY -"PERFORMANCE CHARACTERISTICS OF SIX INTACT PARATHYROID HORMONE ASSAYS" - SONIA L. LA'ULU, WILLIAM L. ROBERTS, (B)(4), WAS CONDUCTED AND FOUND THAT WHILE THE ARCHITECT IPTH ASSAY DOES HAVE A POSITIVE BIAS, IT'S CORRELATION WITH THE OTHER ASSAYS WAS ACCEPTABLE. BASED ON THE RESULTS OF THIS EVALUATION, THE ARCHITECT IPTH REAGENT IS PERFORMING AS INTENDED AND NO PRODUCT ISSUES WERE IDENTIFIED. NO FURTHER INVESTIGATION IS REQUIRED. CATALOG NUMBER CHANGED TO 08K25-27.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ENDOCRINOLOGISTS AT THIS FACILITY CLAIM THAT ARCHITECT IPTH ASSAY RESULTS ARE HIGHER THAN EXPECTED. THE SAMPLE WAS TESTED ON THE ARCHITECT I2000SR ANALYZER AND GENERATED A RESULT OF 52.4 PG/ML (NORMAL RANGE 8.5 TO 72.5 PG/ML). THE SAMPLE WAS THEN SENT TO A REFERENCE LAB AND GENERATED A RESULT OF 27.0 PG/ML (NORMAL RANGE 10 TO 65 PG/ ML) ON A NON-ABBOTT SYSTEM. CONTROLS HAVE BEEN WITHIN SPECIFICATIONS. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT IPTH CEW ABBOTT GERMANY 01911A000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR ARCH I2000SR LN: 03M74-01 SN: (B)(4)