BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM HBSAG

    MDR report key: 2093794 · Received May 18, 2011

    Report

    Report Number
    1415939-2011-00153
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    March 19, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    KSJ
    PMA / PMN Number
    P050049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACCOUNT INDICATED THAT (B)(6) RESULTS WERE OBTAINED ON AN ALTERNATE ASSAY AND FOR ANTIBODY TO HEPATITIS B VIRUS CORE ANTIGEN. THE ACCOUNT ALSO INDICATED THAT RETESTING USING A DIFFERENT LOT OF ABBOTT AXSYM HBSAG (I.E., 01009M600), PRODUCED CONFIRMED (B)(6) RESULTS, WHICH WERE THE EXPECTED RESULTS. A CUSTOMER RETURNED PATIENT SAMPLE WAS PROVIDED TO ASSIST IN THE INVESTIGATION. THE INVESTIGATION TEAM EVALUATED THE RETURNED PATIENT SAMPLE WITH MATERIAL FROM OUR INVENTORY OF AXSYM HBSAG, LOT 94079M500, AND INITIALLY AND REPEATEDLY (B)(6) RESULTS WERE OBTAINED (INITIAL RESULT (S/CO): (B)(6). THE SAMPLE WAS CONFIRMED (B)(6) USING FILE KIT MATERIAL OF AXSYM HBSAG CONFIRMATORY, LOT 91091M500, WITH AXSYM HBSAG, LOT 94079M500. NOTE: EVALUATION OF THE RETURNED PATIENT SAMPLE WITH AXSYM HBSAG, LOT 92872M500, COULD NOT BE PERFORMED SINCE THE MATERIAL WAS EXPIRED. FURTHERMORE, TESTING WITH AXSYM HBSAG, LOT 94129M600, ALSO COULD NOT BE PERFORMED DUE TO SAMPLE EXHAUSTION. THE INVESTIGATION TEAM REVIEWED QUALITY RECORDS TO DETERMINE IF OTHER CUSTOMERS HAD EXPERIENCED SIMILAR ISSUES THAT MIGHT WARRANT FURTHER INVESTIGATION. THE REVIEW DID NOT SHOW ANY UNUSUAL ACTIVITY RELATED TO THE CUSTOMER OBSERVATIONS. BASED ON THIS REVIEW, AS WELL AS THE INVESTIGATIONAL TESTING CONDUCTED, IT IS DETERMINED THAT THE PRODUCT IS PERFORMING AS EXPECTED. THIS INVESTIGATION INDICATES THAT THE PRODUCT IS EFFECTIVE AND IS PERFORMING ACCEPTABLY. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    INTERNAL IDENTIFIER(S): (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. CONCOMITANT MEDICAL PRODUCTS: HBSAG CONFIRMATORY LN 9B01-60. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE ACCOUNT STATED 5 PATIENTS TESTED AXSYM HBSAG REPEAT (B)(6) BUT DID NOT CONFIRM WITH AXSYM HBSAG CONFIRMATORY ASSAY. INITIAL REPORT MENTIONED THIS PATIENT BUT DID NOT HAVE SPECIFIC DATA TO PROVIDE. PATIENT 5 DATA: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM HBSAG IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF HEPATITIS B SURFACE ANTIGENS KSJ ABBOTT LABORATORIES 92872M500

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR AXSYM LIST 7A83-03| AXSYM LIST 7A83-03