BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM REACTION TRAYS

    MDR report key: 1923708 · Received December 14, 2010

    Report

    Report Number
    1415939-2010-00575
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    K970042
    Removal / Correction Number
    1415939-11/23/10-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), CONCOMITANT MEDICAL PRODUCTS: PRISM 6 CHANNEL ANALYZER, LIST # 6A36-04, SERIAL # (B)(4). THE CAUSE OF THE PRISM ERROR CODES FOR THE CALIBRATORS, CONTROLS OR SAMPLES WAS DUE TO AN INCREASE IN DRAIN TIME ERRORS AFFECTING SEVERAL LOTS OF PRISM REACTION TRAYS. A PRODUCT CORRECTION LETTER WAS SENT TO ABBOTT CUSTOMERS WITH INSTRUCTIONS TO DISCONTINUE USE OF THE PRISM REACTION TRAYS WHEN USED IN CONJUNCTION WITH THE PRISM (B)(4) SURFACE ANTIGEN ASSAYS. THE CUSTOMER LETTER ALSO INDICATED THE USE OF PRISM REACTION TRAYS WAS ACCEPTABLE IF NOT UTILIZING THE (B)(4) SURFACE ANTIGEN ASSAYS AND TO CONTINUE USE OF THE AFFECTED REACTION TRAYS UNTIL A NEW LOT OF REACTION TRAYS ARRIVED AT THE CUSTOMER FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVES AN INCREASE IN PRISM DRAIN TIME ERRORS WHEN PRISM REACTION TRAY LOT 90359M500 WAS IN USE. THE CUSTOMER STATED OUT OF A RUN OF 350 SPECIMENS, 25 DRAIN TIME ERRORS WERE GENERATED, HOWEVER, THE CUSTOMER WAS ABLE TO RE-RUN SAMPLES AND GENERATE VALID RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISM REACTION TRAYS REACTION TRAYS FOR PRISM CHEMILUMINESCENT IMMUNOASSAYS JJE ABBOTT LABORATORIES 90359M500

    Patients

    Seq Age Sex Outcome Treatment
    1 PRISM 6 CHANNEL ANALYZER, LIST # 6A36-04