BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 3962631 · Received July 29, 2014

    Report

    Report Number
    3002809144-2014-00158
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION INCLUDED A REVIEW OF COMPLAINT TEXT, COMPLAINT HISTORY, A REVIEW OF LABELING, AND ACCURACY TESTING. THE CUSTOMER OBSERVED ARCHITECT INTACT PTH REAGENT LOT 02213K000 GENERATED FALSELY ELEVATED RESULTS FOR SEVERAL SAMPLES WHICH WERE DISCREPANT WITH A COMPETITOR ASSAY (ROCHE). NO CUSTOMER RETURNS WERE AVAILABLE FOR REVIEW. A REVIEW OF COMPLAINTS RECEIVED TO DATE IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ISSUE OF FALSELY ELEVATED IPTH RESULTS. ACCURACY TESTING WAS PERFORMED USING REAGENT LOT 02213K000 WHICH MET ACCEPTANCE CRITERIA. THE CUSTOMER WAS REFERRED TO A STUDY, "PERFORMANCE CHARACTERISTICS OF SIX INTACT PARATHYROID HORMONE ASSAYS ", SONIA L. LA'ULU, AND WILLIAM L. ROBERTS, MD, PHD. AM J CLIN PATHOL 2010; 134:930-938, 2010) FOR ADDITIONAL INFORMATION. A REVIEW OF LABELING SHOWS THAT INCONSISTENT IPTH RESULTS ARE DISCUSSED ADEQUATELY. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THIS ISSUE. IN ADDITION, THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION HAD OCCURRED. LIMITED TROUBLESHOOTING WAS PERFORMED ON THE INSTRUMENT. ADDITIONALLY, THE PRODUCT CLAIM INDICATES A POSITIVE BIAS TO THE ROCHE ASSAY. NO ADDITIONAL PRODUCT ISSUES WERE IDENTIFIED; NO FURTHER INVESTIGATION IS REQUIRED. BASED ON THE INVESTIGATION IT WAS DETERMINED THAT THE ARCHITECT INTACT PTH ASSAY IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT GENERATED FALSELY ELEVATED IPTH RESULTS ON 3 PATIENTS COMPARED TO ANOTHER LABORATORY'S NON-ABBOTT INSTRUMENT WHICH GENERATED IPTH RESULTS WITHIN REFERENCE RANGE. RESULTS PROVIDED: SID (B)(6) ARCHITECT 72.4 PG/ML (15-68) / REF 41.2PG/ML (10-72); SID (B)(6) 90.5 / REF 56.7; SID (B)(6) 73.1 / REF 42.7. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441059 ARCHITECT IPTH INTACT PARATHYROID HORMONE CEW ABBOTT GERMANY 02213K000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER, LIST #03M74-02,| ARCHITECT I2000SR ANALYZER, LIST #03M74-02,| SERIAL # (B)(4)| SERIAL # (B)(4)