BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2771158 · Received October 3, 2012

    Report

    Report Number
    2531779-2012-11748
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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) 2012 THE REPORTER, THE PATIENT'S MOTHER, CONTACTED ANIMAS TO REPORT THAT FOR THREE DAYS THE PUMP GAVE "LOSS OF PRIME" WARNINGS, TWICE PER DAY. THE PATIENT NOTED HE DID NOT ALWAYS HEAR THESE ALARMS, AND AFTERWARDS DID NOT RECEIVE ANY INSULIN. ON (B)(6) 2012, AFTER LUNCH, THE PUMP GAVE A "LOSS OF PRIME" WARNING, HOWEVER THE PATIENT DID NOT HEAR IT TO CORRECT IT. THE PATIENT OBTAINED THE ELEVATED BLOOD GLUCOSE LEVEL OF "GREATER THAN 500 MG/DL" AND HE TESTED POSITIVE FOR LARGE AMOUNTS OF URINARY KETONES. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PUMP WAS FUNCTIONING APPROPRIATELY BY PROVIDING A WARNING ALARM TO THE USER, INDICATING THE LOSS OF PRIME. THE PATIENT'S TECHNIQUE MAY HAVE BEEN INCORRECT BY NOT ADDRESSING THE LOSS OF PRIME WARNING ALARM. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPERGLYCEMIA AFTER RECEIVING LOSS OF PRIME WARNINGS ON THE PUMP, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening