BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2903722 · Received January 9, 2013

    Report

    Report Number
    2531779-2013-00408
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 14, 2012
    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 PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING HIGH BLOOD GLUCOSE LEVELS OF UNKNOWN CAUSE RESULTING IN HOSPITALIZATION (THE BLOOD GLUCOSE VALUE AT THE TIME OF ADMISSION WAS NOT PROVIDED). THE PATIENT STATED THAT AFTER DISCHARGE FROM THE HOSPITAL, BLOOD GLUCOSE LEVELS WERE AT 398 MG/DL. THE PATIENT REPORTED HAVING A HISTORY OR FIBROMYALGIA AND BLOOD CLOTS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA OF UNKNOWN CAUSE WHILE USING THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12940 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization