BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGM

    MDR report key: 1340052 · Received March 11, 2009

    Report

    Report Number
    1415939-2009-00169
    Event Type
    Malfunction
    Date Received
    March 11, 2009
    Date of Event
    February 18, 2009
    Report Date
    February 18, 2009
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LFX
    PMA / PMN Number
    K954318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF COMPLAINT DATA WAS PERFORMED TO ASSESS THE PERFORMANCE OF THE ASSAY. CUSTOMER COMPLAINTS RECEIVED TO-DATE WERE REVIEWED TO DETERMINE IF OTHERS HAVE EXPERIENCED THE SAME ISSUE. OUR REVIEW OF THIS DATA DID NOT IDENTIFY ANY PROBLEMS. SPECIFICALLY, WE DID NOT SEE AN INCREASE IN THE NUMBER OF COMPLAINTS RELATED TO DISCREPANT RESULTS WHILE USING THE REAGENT LOT NUMBER IN QUESTION. THE INFORMATION PROVIDED BY THE CUSTOMER'S LABORATORY WAS REVIEWED AND IT WAS NOTED THAT THE CUSTOMER DOES NOT PERFORM REGULAR INSTRUMENT MAINTENANCE. THE CUSTOMER WAS REFERRED TO THE AXSYM SYSTEM OPERATIONS MANUAL, SECTION 9 (SERVICE AND MAINTENANCE), WHICH INSTRUCTS THAT TUBING DECONTAMINATION SHOULD BE PERFORMED ONCE A MONTH AND IT IS RECOMMENDED THE MEIA VERIFICATION BE PERFORMED ONCE A WEEK TO ENSURE THE REPRODUCIBILITY AND ACCURACY OF THE MEIA OPTICAL ASSEMBLY. BASED ON THE RESULTS OF THIS INVESTIGATION, AXSYM RUBELLA IGM REAGENT LOT 63373M200 IS PERFORMING AS INTENDED AND NO ADDITIONAL PRODUCT ISSUES WERE IDENTIFIED. NO FURTHER INVESTIGATION IS REQUIRED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A FALSE POSITIVE RESULT WAS GENERATED ON THE AXSYM RUBELLA IGM ASSAY. A PREGNANT PATIENT GENERATED A GRAYZONE INDEX VALUE OF 0.637. THE SAMPLE WAS CENTRIFUGED AND RETESTED YIELDING A POSITIVE INDEX VALUE OF 0.930. A SECOND SAMPLE WAS OBTAINED FROM THIS PATIENT AND GENERATED A NEGATIVE INDEX VALUE OF 0.579. THIS PATIENT ALSO TESTED NEGATIVE ON A CHEMILUMINESCENCE METHOD. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 1

    PER EXPLANTING SURGEON THE DEVICE WAS KNOWN TO FAIL. SURGEON HAD BEEN NOTIFIED SEVERAL YEARS AGO BY THE MANUFACTURER OF A VOLUNTARY RECALL. WE WAITED UNTIL THE DEVICE DID FAIL BEFORE REMOVING AND REPLACING IT WITH A NEW COCHLEAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM RUBELLA IGM FOR THE MEASUREMENT OF IGM ANTIBODY TO THE RUBELLA VIRUS LFX ABBOTT LABORATORIES 63373M200

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER LIST # 7A83-01