BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1972263 · Received January 20, 2011

    Report

    Report Number
    2531779-2011-00380
    Event Type
    Injury
    Date Received
    January 20, 2011
    Report Date
    December 23, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT'S MOM INDICATED THAT THE PT'S BLOOD GLUCOSE (BG) HAD BEEN IN THE 250-350 MG/DL RANGE FOR 3 DAYS AND HAD TESTED POSITIVE FOR KETONES. THE PT WAS TREATED WITH INSULIN INJECTIONS, PER HIS HEALTH CARE PROFESSIONAL'S PROTOCOL. THE PT REPORTEDLY DID NOT HAVE ANY ILLNESSES OR INFECTIONS BUT IS GOING THROUGH A GROWTH SPURT. THE PT'S MOM ALSO DENIED ANY ISSUES WITH THE INFUSION SITE AND INFUSION SITE. THE PT HAD ALSO SEEN THE ENDOCRINOLOGIST THIS WEEK AND NO CHANGES WERE MADE TO THE PUMP SETTINGS. THE PT'S MOM STATED THAT IN THE PAST, SHE HAD ADJUSTED THE BASAL RATES AND NOT THE HEALTH CARE PROFESSIONAL. THE ANIMAS REPRESENTATIVE WENT THROUGH TROUBLESHOOTING WITH THE PT'S MOM AND NOTED THE FOLLOWING: THE PUMP SETTINGS WERE CORRECT, THE PAST 5 BOLUS WERE DELIVERED IN FULL, THERE WERE NO ASSOCIATED ALARMS IN THE PUMP'S HISTORY, THE BASAL DELIVERED IN FULL FOR THE PAST 3 DAYS. THE ANIMAS REPRESENTATIVE CONCLUDED THERE WAS NO INDICATION OF A PUMP MALFUNCTION BASED ON THE TROUBLESHOOTING. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGEDLY DEVELOPED ELEVATED BLOOD GLUCOSE AND TESTED POSITIVE FOR KETONES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening