BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222232 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10373
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 437MG/DL WITH VOMITING AND WAS SEVERELY DEHYDRATED. THE PATIENT REPORTEDLY DID NOT TEST FOR KETONES. THE PATIENT REPORTEDLY TREATED VIA CORRECTION INJECTION. IT WAS NOTED THAT THE PATIENT ADMITTED TO NOT EATING MUCH AND THEN EXPERIENCED SEVERE DEHYDRATION WHEN HE DISCONNECTED FROM THE PUMP. THE PATIENT STATED THAT HE EXPERIENCED THE REPORTED EVENT DUE TO HIM WAITING FOR THE NEW PUMP AND USING THE ALTERNATE FORM OF INSULIN DELIVERY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. USER ERROR CONTRIBUTED TO THE REPORTED EVENT DUE TO THE FOLLOWING; THE PATIENT WAS NOT EATING AND HAD DISCONNECTED FROM THE PUMP AND WAS USING AND INADEQUATE BACK UP FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322328 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR