BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2192454 · Received August 5, 2011

    Report

    Report Number
    2531779-2011-05631
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHORTLY AFTER A CARTRIDGE CHANGE, THE PUMP REBOOTED. THE PATIENT REPORTED THAT THE PUMP CHIRPED, DID NOT RESPOND TO BUTTON PUSH, THEN THE PATIENT PRESSED A BUTTON AGAIN AND PUMP SHOWED HOURGLASS FOLLOWED BY VERIFICATION SCREEN. THE PATIENT REPORTED THAT THE PUMP BATTERY CAP WAS SECURE AND INTACT WITH NO YELLOW O-RING SHOWING AT THE TIME OF THE CALL. CUSTOMER SUPPORT FELT THAT IT WAS UNCLEAR IF THE BATTERY CAP WAS PROPERLY SECURED AT THE TIME OF THE REPORTED REBOOT. THE PATIENT'S BLOOD GLUCOSE REPORTEDLY REMAINED AT 90 MG/DL DURING THIS ISSUE. THE PATIENT REPORTED THAT SINCE THE INCIDENT THE PUMP HAS APPEARED TO BE WORKING APPROPRIATELY. THE PATIENT CONTINUED TO WEAR THE PUMP AND THERE HAVE BEEN NO FURTHER REPORTED INCIDENTS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PUMP MAY HAVE REBOOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR