BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTHERA-PUNCHER 9

    MDR report key: 3925175 · Received June 26, 2014

    Report

    Report Number
    8043909-2014-00001
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    WALLAC OY
    Product Code
    LXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION HAS SHOWN THAT THE IONIZER MAY DECREASE THE REACTION SIGNAL LEVEL OF ASSAYS USING ANTIBODY COATED PLATES (SUCH AS THOSE USED FOR IMMUNOASSAYS). WE HAVE ALSO FOUND THAT UNCOATED PLATES (SUCH AS THOSE USED FOR ENZYMATIC ASSAYS) ARE NOT AFFECTED BY THE PHENOMENON. THE PHENOMENON HAS BEEN DETERMINED TO BE LOCALIZED TO WELLS LOCATED BENEATH OR ADJACENT TO WELLS BENEATH THE IONIZER PINS WHEN THE PANTHERA-PUNCHER 9 IS IDLE OR IN SLEEP MODE. OUR INVESTIGATION INTO THE PHENOMENON HAS DETERMINED CONTRIBUTING FACTORS TO BE THE POSITION OF THE PLATE BENEATH THE IONIZER, THE PERIOD OF TIME THE PLATE IS STATIONARY BENEATH THE IONIZER AND THE VOLTAGE OF THE IONIZER UNIT. THE SOFTWARE CURRENTLY ALLOWS THE IONIZER TO REMAIN ACTIVE WHEN THE PUNCHER IS IDLE OR HAS GONE INTO SLEEP MODE. UNDER THESE CERTAIN CONDITIONS THE IONIZER MAY NEGATIVELY IMPACT SAMPLES RESULTS.

    Description of Event or Problem · 1

    THROUGH A CUSTOMER COMPLAINT REPORTED ON (B)(6) 2014, WE BECAME AWARE THAT EXTENDED EXPOSURE IN CLOSE PROXIMITY TO THE IONIZER PINS OF THE PANTHERA-PUNCHER 9 CAN DECREASE THE REACTION SIGNAL LEVEL OF ASSAYS USING ANTIBODY COATED MICROTITER PLATES (SUCH AS THOSE USED FOR IMMUNOASSAYS). NO FALSE NEGATIVE OR FALSE POSITIVE RESULTS ARE KNOWN TO HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373603 PANTHERA-PUNCHER 9 PANTHER PUNCHER LXG WALLAC OY 2081-0010

    Patients

    Seq Age Sex Outcome Treatment
    1