BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 2993148 · Received March 7, 2013

    Report

    Report Number
    1628664-2013-00053
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) SERVICED THE AXSYM ANALYZER AND REPLACED A WORN PROCESSING PROBE. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THE AXSYM SYSTEM OPERATIONS MANUAL AND THE AXSYM CMV IGG ASSAY PACKAGE INSERT BOTH CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. 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 PRODUCT EVALUATION FOUND A PATIENT DISCREPANT RESULT ISSUE WAS RESOLVED THROUGH NORMAL MAINTENANCE PROCEDURES INCLUDING THE REPLACEMENT OF THE WORN PROCESSING PROBE. THE INFORMATION PROVIDED SUGGESTS THE DEVICE IS PERFORMING AS INTENDED WHEN PROPERLY MAINTAINED. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS PREVIOUSLY SUBMITTED UNDER MFR REPORT NO. 1415939-2013-00070. THE SUSPECT MEDICAL DEVICE CHANGED FROM THE AXSYM CMV IGG ASSAY, LIST: 04B47-20 TO THE ABBOTT AXSYM SYSTEM, LIST: 07A83-01. 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

    THE CUSTOMER REPORTS A (B)(6) RESULT FOR ONE PATIENT. (B)(6). CONTROLS HAVE REMAINED WITHIN SPECIFICATIONS. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB WITH NO IMPACT TO PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98134 ABBOTT AXSYM SYSTEM JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM PROBE LIST: 09A59-01| AXSYM CMV IGG LN: 04B47-20, LOT: 16486M500| AXSYM PROBE LIST: 09A59-01| AXSYM CMV IGG LN: 04B47-20, LOT: 16486M500