BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2172110 · Received July 22, 2011

    Report

    Report Number
    2531779-2011-05118
    Event Type
    Injury
    Date Received
    July 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED THAT THE KEYPAD IS LIFTING UNDER THE OK BUTTON. CONTAMINATION WAS PRESENT UNDER THE KEYPAD BUTTON CONTACTS. THE BUTTONS WERE INVERTED AND DID NOT SPRING BACK OR CLICK NORMALLY. TESTING CONFIRMED THAT KEYPAD BUTTONS INTERMITTENTLY ACTIVATED PUMP FUNCTIONS WHEN PRESSED. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE KEYPAD BUTTONS WERE NOT ACTIVATING DESIRED PUMP FUNCTIONS WHEN PRESSED. HE SAYS HE BECAME AWARE OF THE ISSUE BECAUSE HE PROGRAMMED A BOLUS DOSE OF 16 UNITS AND 3.5 HOURS LATER HE SAID HIS BLOOD GLUCOSE FELT ELEVATED. HE SAID HIS BLOOD GLUCOSE LEVEL WAS IN THE 300 MG/DL RANGE AND HE SAID HE HAD FREQUENT URINATION. THE PATIENT CHECKED HIS BOLUS HISTORY WHICH REVEALED THAT 0 OF THE 16 PROGRAMMED UNITS WAS DELIVERED. THE PATIENT SAID HE DOES NOT RECALL SEEING A BOLUS CANCELLED MESSAGE BUT STATES THAT HE IS SOMETIMES HARD OF HEARING. HE SAYS HE HAS TO PUSH BUTTONS THREE TIMES AND MOVE THE BUTTONS TO ACTIVATE A DESIRED PUMP RESPONSE. HE SAID THE ISSUE OCCURS WITH THE OK, UP, AND DOWN ARROW BUTTONS. THE PATIENT REPORTEDLY CLEANS THE PUMP WITH DRY CLOTH.

    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 36 YR Life Threatening