BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3190230 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09006
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LOSS OF PRIME ALARMS ARE NOT LIKELY TO CAUSE AN ADVERSE EVENT, AS THE PUMP WILL ALARM TO ALERT THE USER OF THE ISSUE. THE OWNER¿S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON. THE PUMP HAS NOT BEEN REQUESTED FOR RETURN. 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PUMP KEPT EMITTING LOSS OF PRIME ALARMS AND THE PATIENT SUBSEQUENTLY EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OVER 400MG/DL WITH NAUSEA AND VOMITING. THE PATIENT WAS REPORTEDLY GIVEN CORRECTION INJECTIONS TO BRING BG DOWN. DURING TROUBLESHOOTING, THE REPORTER NOTED A PATTERN OF THE LOSS OF PRIME ALARMS BEING AROUND TIMES OF INCREASED ACTIVITY. THE REPORTER NOTED THAT THE PATIENT SWINGS THE PUMP AND LIKES TO ¿TWIRL THE PUMP ROUND AND ROUND¿. CUSTOMER TECHNICAL SUPPORT ADVISED THAT THIS COULD LOOSEN THE CARTRIDGE CAP AND CAUSE LOSS OF PRIMES. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY DUE TO USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290716 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening