BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 3240279 · Received July 22, 2013

    Report

    Report Number
    1415939-2013-00298
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 16, 2013
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CEW
    PMA / PMN Number
    K063232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCURACY TESTING WAS PERFORMED ACROSS THREE ARCHITECT ANALYZERS USING RETAINED KITS OF ARCHITECT PTH ASSAY LOT 00212K000. THREE LEVELS OF THE PTH ANALYTE WERE ANALYZED ON EACH INSTRUMENT. ALL RESULTS MET ACCEPTANCE CRITERIA INDICATING THAT REAGENT LOT IS PERFORMING ACCEPTABLY. 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 PTH ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE RESULTS OF THE CURRENT EVALUATION, IT WAS CONCLUDED THAT THE ARCHITECT INTACT PTH ASSAY IS PERFORMING AS INTENDED. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED. MANUFACTURER WAS INCORRECT IN THE INITIAL MDR SUBMISSION. CORRECT MANUFACTURER IS ABBOTT (B)(4). CONCOMITANT PRODUCT LIST NUMBER WAS INCORRECT IN THE INITIAL MDR SUBMISSION. THE CORRECT LIST NUMBER FOR THE ARCHITECT I2000SR ANALYZER IS LN: 03M74-02. MANUFACTURING SITE FOR DEVICE WAS INCORRECT IN THE INITIAL MDR SUBMISSION. THE CORRECT MANUFACTURING SITE FOR THE DEVICE IS ABBOTT (B)(4). (B)(4)

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PHYSICIAN QUESTIONED HIS OWN FALSELY DECREASED ARCHITECT IPTH ASSAY RESULT OF 20 PG/ML GENERATED ON AN ARCHITECT I2000SR ANALYZER. THE SAMPLE WAS STORED FROZEN AFTER TESTING. THE PHYSICIAN STATED THAT HIS LAST PTH RESULT OF 120 PG/ML WAS GENERATED AT A DIFFERENT FACILITY (METHODOLOGY UNKNOWN). THREE DAYS LATER, THE PRESENT SAMPLE WAS THAWED AND RECENTRIFUGED AND TESTED WITH A RESULT OF 91 PG/ML. THE CUSTOMER THEN RECHECKED SEVERAL OTHER IPTH SAMPLES FROM PREVIOUS DAYS' TESTING AND ALL CORRELATED WITH THEIR INITIAL RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339439 ARCHITECT IPTH CEW ABBOTT GERMANY 00212K000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR LN:03M74-02, SN: (B)(4)| ARCHITECT I2000SR LN:03M74-01, SN: (B)(4)