BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1962510 · Received January 4, 2011

    Report

    Report Number
    2531779-2011-00015
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER REMOTE WAS RETURNED TO ANIMAS FOR EVALUATION. THE PUMP WAS NOT RETURNED WITH THE METER. A TEST PUMP WAS USED FOR TESTING PURPOSES. NO ACTIVITY OUTSIDE NORMAL USE WAS OBSERVED IN THE METER HISTORY. THE PUMP AND METER POWERED UP NORMALLY AND PAIRED SUCCESSFULLY. AN EZCARB BOLUS WAS SUCCESSFULLY PERFORMED FROM THE METER AFTER A BLOOD GLUCOSE CHECK. BOLUSES WERE EXECUTED USING THE METER REMOTE WITH NO ERRORS OCCURRING. THE METER PASSED RF TESTING. ANALYSIS OF THE METER REMOTE WAS UNABLE TO CONFIRM OR DUPLICATE THE COMPLAINT.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PATIENT CONTACTED ANIMAS ALLEGING THAT THE METER REMOTE WAS NOT SENDING INFORMATION TO THE PUMP. THE PATIENT CLAIMED THAT AFTER HE WOULD TEST HIS BLOOD GLUCOSE ON THE METER REMOTE, ENTER HIS CARBOHYDRATES, PROGRAM A BOLUS, AND PRESS 'OK' FOR THE BOLUS, THE DEVICE WOULD GET STUCK ON THE HOURGLASS SYMBOL. THE PATIENT CLAIMED THAT THE METER REMOTE WOULD NOT DO ANYTHING UNTIL THE BATTERY WAS REMOVED. ON THE NIGHT OF (B)(6) 2010, THE PATIENT CLAIMED THAT THE DEVICE GOT STUCK ON THE HOURGLASS SYMBOL AFTER PROGRAMMING A 1.45 UNIT BOLUS. AFTER REMOVING AND REINSERTING THE BATTERIES OF THE METER REMOTE, HE REPORTEDLY DELIVERED A 1.00 UNIT BOLUS. THE PATIENT CLAIMED THAT HIS BLOOD GLUCOSE (BG) WENT DOWN TO 45-50 MG/DL AND HE HAD DEVELOPED A SYMPTOM OF SLURRED SPEECH WHICH IS COMMON FOR HIM FOR LOW BG'S. AFTER RECEIVING TREATMENT WITH GLUCOSE TABLETS, THE PATIENT CLAIMED THAT HIS BLOOD GLUCOSE LEVEL WENT UP TO 112 MG/DL. THE PATIENT WAS CONCERNED THAT HE HAD RECEIVED A TOTAL BOLUS AMOUNT OF 2.45 UNITS. A REVIEW OF THE PUMP REVEALED THAT 0 UNITS WERE DELIVERED AT THE TIME THE HOURGLASS GOT STUCK ON THE METER REMOTE SCREEN. THE PUMP HISTORY INDICATED THAT 1.0 UNITS WERE DELIVERED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED A SYMPTOM THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER ATTEMPTING TO THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP (SYSTEM) LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening