BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1902509 · Received November 12, 2010

    Report

    Report Number
    2531779-2010-02262
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANIMAS REPRESENTATIVE WENT THROUGH TROUBLESHOOTING WITH THE PATIENT'S DAD AND NOTED THE FOLLOWING: THE PT CLAIMED THERE WERE NO AIR BUBBLES IN THE TUBING, NO SITE ISSUES, NO LEAKING, AND NO KINKS IN THE CANNULA, THERE WERE NO ALARMS IN THE PAST SEVERAL DAYS IN THE PUMP HISTORY, THE TOTALS OF INSULIN DELIVERED WERE CORRECT, AND THE DATE/TIME SETTING WAS CORRECT. 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

    IT WAS REPORTED THAT THE PT WAS HOSPITALIZED WITH ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT'S DAD AND PT CONTACTED ANIMAS BECAUSE THEY WANTED TO RULE OUT THE PUMP AS THE CAUSE OF THE ELEVATED BLOOD GLUCOSE LEVELS. THE PT STATED 2 WEEKS AGO, SHE WANTED TO SEE IF SHE CAN USE THE PUMP FOR BASAL DELIVERIES AND USE INJECTIONS FOR BOLUSES. THE PATIENT'S MOST RECENT BOLUS WAS TAKEN LAST NIGHT (8.8 UNITS) AND BEFORE THAT THE LAST BOLUS WAS DELIVERED ON (B)(6), 2010. THE PT CLAIMED THAT HER BLOOD GLUCOSE LEVEL HAS BEEN IN THE LOW 200S MG/DL WITH INJECTIONS. ON AN UNSPECIFIED DATE, THE PT DEVELOPED A HEAD COLD/ILLNESS AND THEN SHE DEVELOPED SYMPTOMS OF THIRST, NAUSEA, AND VOMITING WHICH STARTED YESTERDAY. THE PT WAS TAKEN TO THE EMERGENCY ROOM: HER BLOOD GLUCOSE LEVEL WAS 473 MG/DL UPON ARRIVAL. THE PT WAS TREATED WITH AN INSULIN SYRINGE, WAS TAKEN OFF THE PUMP, AND THEN PUT ON AN INSULIN DRIP. THE ANIMAS REPRESENTATIVE REVIEWED THE PUMP SETTINGS AND HISTORY AND DID NOT FIND ANY MALFUNCTION OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization