BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM CREATININE KINASE MB

    MDR report key: 2498765 · Received March 21, 2012

    Report

    Report Number
    3005094123-2012-00018
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Report Date
    March 1, 2012
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    JLB
    PMA / PMN Number
    K935924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE REAGENT KIT USED BY THE CUSTOMER NOR THE PATIENT SAMPLE IN QUESTION WERE AVAILABLE FOR RETURN, THEREFORE, ACCURACY TESTING WAS PERFORMED WITH QUALITY FILE SAMPLES OF AXSYM CK-MB REAGENT LOT 05235JN00 AND PANELS WHICH SIMULATED PATIENT SAMPLES. VALIDITY AND ACCEPTANCE CRITERIA WERE MET, INDICATING THE REAGENT LOT IS PERFORMING ACCEPTABLY AND WITHIN LABEL CLAIMS. (B)(4). BASED ON THE INFORMATION IN THE CUSTOMER COMPLAINT, EVALUATION OF THE ISSUE REASONABLY SUGGESTS A MALFUNCTION OCCURRED AT THE CUSTOMER SITE. ADDITIONALLY, NO PRODUCT DEFICIENCY WAS IDENTIFIED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED AXSYM CKMB PATIENT RESULTS WHICH WERE NOT CONSISTENT WITH THE PATIENT'S CLINICAL HISTORY . THE CUSTOMER PROVIDED THE FOLLOWING RESULTS IN NG/ML: (B)(6) 2012: AXSYM CKMB, 109.7; (B)(6) 2012: ARCHITECT CKMB, 81.7; (B)(6) 2012: AXSYM CKMB: 7.1. THE FALSELY ELEVATED CKMB RESULTS WERE NOT REPORTED OUT OF THE LAB, THEREFORE, THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM CREATININE KINASE MB JLB A.I.D.D LONGFORD 05235JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER, LIST # 7A83-01, SN (B)(4)| AXSYM ANALYZER, LIST # 7A83-01, SN (B)(4)