BEUDAMED
    FDA Adverse Event Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2950010 · Received February 8, 2013

    Report

    Report Number
    2531779-2013-01594
    Date Received
    February 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 SUBMITTED 03/04/2013: 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013, ALLEGING SHE EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OF 358 MG/DL WITH EXTREME THIRST, FATIGUE AND NAUSEA. THE PATIENT DENIED THE PRESENCE OF KETONES. THE PATIENT DENIED NEEDING MEDICAL INTERVENTION FOR THE ELEVATED BG AND STATED SHE WOULD TREAT THE ELEVATION HERSELF. THE PATIENT ALLEGED THE PUMP HAD BEEN MALFUNCTIONING FOR WEEKS EVIDENCED BY FREQUENT LOSS OF PRIME. THE PATIENT DECLINED TO TROUBLESHOOT THE PUMP WITH ANIMAS CUSTOMER TECHNICAL SUPPORT (ACTS) AT THE TIME OF THE CALL. ACTS ADVISED THE PATIENT TO CALL BACK TO DISCUSS THE ISSUE AND THE PATIENT AGREED TO DO SO. ACTS MADE SEVERAL ATTEMPTS TO CONTACT THE PATIENT BACK IN FOLLOW UP OF THE REPORTED BG AND TO TROUBLESHOOT THE PUMP, BUT THE PATIENT DID NOT RESPOND TO THOSE ATTEMPTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED ELEVATED BG WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53948 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Life Threatening