BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 5993441 · Received October 3, 2016

    Report

    Report Number
    3002809144-2016-00083
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    June 15, 2016
    Report Date
    April 24, 2017
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE ARCHITECT INTACT PTH ASSAY RESULTS WERE ELEVATED WHEN TESTING PATIENT RESULTS. A REVIEW OF COMPLAINT REPORTS RECEIVED TO DATE IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THIS ISSUE. ACCURACY TESTING WAS PERFORMED WITH A FILE KIT OF LOT 00715G000 AND ALL RESULTS MET ACCEPTANCE CRITERIA. A REVIEW OF LABELING FOUND THAT THE CUSTOMER ISSUE OF FALSELY ELEVATED IPTH PATIENT RESULTS WAS ADEQUATELY ADDRESSED. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED FOR THIS ISSUE. IN ADDITION, THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION HAD OCCURRED. BASED ON THIS INVESTIGATION IT HAS BEEN DETERMINED THAT THE ARCHITECT INTACT PTH ASSAY, LOT 00715G000 IS PERFORMING AS INTENDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE THE DEVICE WAS NOT PERFORMING AS INTENDED, AND CONCLUSIONS CODE WAS CORRECTED FROM (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY ELEVATED IPTH RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: 15JUN2016 = 107PG/ML / 06JUL2016 = 116PG/ML / RESULTS PRIOR TO LUMPECTOMY ON 12SEP2016 = 60.0PG/ML / ANOTHER ANALYZER = 58.8PG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645997 ARCHITECT IPTH INTACT PARATHYROID HORMONE CEW ABBOTT GERMANY 00715G000

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,| SERIAL # (B)(4)