BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2963073 · Received February 15, 2013

    Report

    Report Number
    2531779-2013-01813
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF HI ON THE METER (OVER 600 MG/DL). THE REPORTER STATED THAT THE PATIENT EXPERIENCED THE HIGH BLOOD GLUCOSE RELATED TO BEING OVERHEATED AND INDICATED THAT THE PATIENT NORMALLY HAD ELEVATED BLOOD GLUCOSE LEVELS WHEN OVERHEATED. THE REPORTER STATED THAT THE PATIENT TOOK A CORRECTION BOLUS STARTED COOLING OFF AND THE PATIENT'S BLOOD GLUCOSE REPORTEDLY RETURNED TO 146 MG/DL. THE REPORTER DECLINED TROUBLESHOOTING OF THE PUMP AS THE REPORTER DID NOT FEEL THAT THE PUMP WAS THE CAUSE OF THE HIGH BLOOD GLUCOSE LEVELS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67196 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening