BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT COMMANDER FPC

    MDR report key: 990354 · Received February 4, 2008

    Report

    Report Number
    1628664-2008-00030
    Event Type
    Malfunction
    Date Received
    February 4, 2008
    Report Date
    January 9, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC
    Product Code
    JQW
    PMA / PMN Number
    K894069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER CODES: (FLEXIBLE PIPETTOR CENTER, HTLV-I/II ASSAY WAS BEING ANALYZED). SERVICE PERFORMED ALIGNMENT ADJUSTMENTS AND PERFORMED ALL REQUIRED VERIFICATIONS AND CONTROLS. ALL PASSED WITHIN SPECS, THE ANALYZER IS OPERATIONAL AND REQUIRED NO FURTHER INVESTIGATION. THE ACCOUNT STATED THAT THERE HAVE BEEN NO MORE OCCURRENCES OF MANY LOW FLAGS FOR HTLV-I/II SINCE THE SERVICE VISIT. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THEY HAD SEVERAL LOW ERRORS WITH HTLV-I/II EIA REAGENT LOTS 56636M200 AND 58110M102 WITH THE COMMANDER FPC AND COMMANDER PPC WITHIN THE LAST MONTH. THE ACCOUNT IS FOLLOWING THE PRODUCT CORRECTION LETTER INSTRUCTIONS PROPERLY. SERVICE WAS REQUESTED FOR ALL 3 COMMANDER FPC'S AND ALL 3 COMMANDER PPC'S. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT COMMANDER FPC AUTOMATED SYSTEM FOR THE PROCESSING OF EIA'S JQW ABBOTT MANUFACTURING, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LOTS 56636M200 AND 58110M102| HTLV-I/II EIA LIST 7A92-32