BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2042190 · Received March 28, 2011

    Report

    Report Number
    2531779-2011-02035
    Event Type
    Injury
    Date Received
    March 28, 2011
    Report Date
    February 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED THAT APPROX 6 MONTHS PRIOR TO CONTACTING ANIMAS, HE WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND HOSPITALIZED DUE TO A LOW BLOOD GLUCOSE (BG) OF 40 MG/DL. THE PT ALSO CLAIMED THAT SINCE THE ACCIDENT, ON NUMEROUS OCCASIONS (DATES/TIMES NOT PROVIDED), HE HAS BEEN TREATED BY PARAMEDICS FOR LOW BGS (30 TO 40 MG/DL). THE PT WAS UNABLE TO PROVIDE INFORMATION REGARDING THE HOSPITALIZATION, DATES, OR EVENTS LEADING TO THE LOW BGS. THE PT INFORMED THE CUSTOMER SERVICE REP (CSR) THAT MOST OF THE TIME HE HAS BEEN ASYMPTOMATIC AT THE TIME OF THE LOW BGS. AT THE TIME OF TROUBLESHOOTING, THE CSR REVIEWED PUMP HISTORY AND NOTED THE ONLY ALARM IN THE PAST SEVERAL DAYS WAS FOR A LOW OR EMPTY CARTRIDGE. BOLUS HISTORY WAS ALSO REVIEWED AND THE PT CONFIRMED ALL BOLUSES WERE DELIVERED APPROPRIATELY. THE PUMP'S DATE, TIME, BASAL AND ADVANCED BOLUS SETTINGS WERE ALSO CONFIRMED TO BE CORRECT. THE CSR NOTED THAT THE PT PRIMES THE PUMP AS INSTRUCTED. THE PT DENIED ANY CHANGES IN MEDICATIONS, ACTIVITY, OR FOOD/ALCOHOL INTAKE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE LOW BGS. DURING TROUBLESHOOTING, IT WAS DETERMINED THAT THE CURRENT PUMP SETTINGS AND DELIVERY HISTORY WERE ACCURATE. THE PT WAS ADVISED TO F/U WITH HIS HCP REGARDING LOW BG AND PUMP SETTINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L