BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4111394 · Received September 23, 2014

    Report

    Report Number
    2531779-2014-27176
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    March 31, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON (B)(6) 2014, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OVER 600 MG/DL WITH DIABETIC KETOACIDOSIS. IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE HOSPITAL VIA AMBULANCE AND WAS TREATED IN THE EMERGENCY ROOM BY THEIR HEALTHCARE PROVIDER WITH IV FLUIDS. IT WAS REPORTED THAT THE PATIENT DID NOT DO WELL ON THE PUMP WITH INSULIN. ADDITIONAL INFORMATION WAS NOT PROVIDED AND THE REPORTER DECLINED TO RETURN THE PUMP. THERE WAS NO INDICATION OR ALLEGATION OF A PUMP MALFUNCTION AT THE TIME OF THE CALL TO ANIMAS; HOWEVER A CLEAR CAUSE OF THE ALLEGED BG EXCURSION WAS NOT DETERMINED. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPERGLYCEMIA OF UNKNOWN CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589932 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R