BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2801912 · Received October 23, 2012

    Report

    Report Number
    2531779-2012-12660
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    September 28, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CLAIMED SHE DEVELOPED ELEVATED BLOOD GLUCOSE OF 424 MG/DL AND HAD SYMPTOM OF SWEATING, NAUSEA, AND THIRST BECAUSE SHE HAD TO DISCONNECT FROM INSULIN PUMP THERAPY TO RESOLVE THE CALL SERVICE ALARMS. THE PATIENT WAS ABLE TO RESOLVE THE CALL SERVICE ALARM ISSUE AND IS CURRENTLY BACK ON INSULIN PUMP THERAPY. AFTER THE PATIENT TOOK 15 UNITS OF INSULIN, HER SYMPTOMS ABATED WHILE SHE TESTED AT 343 MG/DL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening