BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT 6+ CARTRIDGE

    MDR report key: 1022465 · Received March 31, 2008

    Report

    Report Number
    2245578-2008-00010
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    July 12, 2007
    Report Date
    March 25, 2008
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Removal / Correction Number
    Z-0370/375-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A COMPONENT ON THE COVER OF THE CARTRIDGE CALLED THE SNAP CLOSURE. THE SNAP CLOSURE CREATES AN AIRTIGHT SEAL NECESSARY FOR PROPER FLUID MOVEMENT WITHIN THE CARTRIDGE. THE CLOSURE ENSURES THE CALIBRANT AND SAMPLE REMAIN CONTAINED WITHIN THE CARTRIDGE DURING THE TESTING CYCLE AND SUBSEQUENT DISPOSAL. THE USER IS INSTRUCTED TO FOLD THE SNAP CLOSURE OVER THE SAMPLE WELL AND TO PRESS THE ROUNDED END OF THE CLOSURE UNTIL IT SNAPS INTO PLACE AFTER A LOADING SAMPLE. THE SNAP CLOSURE REMAINS IN PLACE BY A LATCH HOOK. IN THE CASE OF THIS PRODUCT ISSUE, THE SNAP CLOSURE WAS HARD TO CLOSE AND/OR DID NOT REMAIN CLOSED. AN INVESTIGATION IDENTIFIED AN ASSIGNABLE CAUSE FOR THE ISSUE; A NON-OPTIMAL DIMENSION OF THE SNAP CLOSURE MECHANISM. IT WAS FOUND THAT WHEN THE DIMENSION OF THE LATCH HOOK IS CLOSER TO THE LOWER END OF THE SPECIFICATION MORE FORCE IS REQUIRED TO ENGAGE THE HOOK WITH THE UNDERSIDE OF THE COVER THAN WHEN IT IS TOWARD THE UPPER END OF THE SPECIFICATION. CONSEQUENTLY, THE PROBABILITY IS HIGHER THAT A FORCE IS GENERATED UPON CLOSURE OF THE LATCH THAT IS LARGE ENOUGH TO DEFORM THE PLASTIC WHERE THE HOOK MUST ENGAGE WITH THE UNDERSIDE OF THE COVER. ONCE THE PLASTIC IS DEFORMED, THE SNAP CLOSURE CANNOT CLOSE OR WILL NOT REMAIN CLOSED.

    Description of Event or Problem · 1

    A CUSTOMER STATED THE SNAP CLOSURE ON AN I-STAT 6+ CARTRIDGE IS DIFFICULT TO CLOSE. THERE WAS NO REPORT OF ANY INJURY ASSOCIATED WITH THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT 6+ CARTRIDGE IVD JJE ABBOTT POINT OF CARE INC. NA D07116

    Patients

    Seq Age Sex Outcome Treatment
    1