BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3181472 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08707
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    ON (B)(6) 2013, THE PATIENT REPORTED HOSPITALIZATION ON (B)(6) 2013 FOR HYPERGLYCEMIA WITH KETONES. THE PATIENT ACKNOWLEDGED THE FOLLOWING SYMPTOMS: MODERATELY INCREASED THIRST, FREQUENT URINATION, AND FATIGUE. IT WAS REPORTED THAT THE BLOOD GLUCOSE (BG) MEASURED HI ON ADMISSION; PUMP WAS DISCONTINUED IN FAVOR OF INTRAVENOUS INSULIN DRIP. THE PATIENT REPORTED THE FOLLOWING HISTORY OF EVENTS: BG WAS ELEVATED (ABOUT 300MG/DL OR MORE) ON (B)(6) 2013. ON (B)(6) 2013, THE INFUSION SET WAS CHANGED; PREVIOUS SITE CHANGE WAS ON (B)(6) 2013. WHILE HOSPITALIZED THE PATIENT¿S BG WAS 141MG/DL ON THE EVENING OF (B)(6) 2013 AND 500MG/DL IN THE MORNING OF (B)(6) 2013. DURING TROUBLE SHOOTING, IT WAS NOTED THAT THE PRIMING AMOUNT WAS INADEQUATE TO FILL THE TUBING (3.3-7.5 UNITS FOR 23¿ TUBING). ADDITIONALLY THE PATIENT REMOVED THE INFUSION SET AND REPORTED THAT IT WAS BENT. THERE WERE NO ASSOCIATED ALARMS IN THE HISTORY. CUSTOMER TECHNICAL SUPPORT INSTRUCTED THE PATIENT ON CORRECT PRIMING TECHNIQUE AND ADVISED TO CHANGE THE INFUSION SET EVERY 2-3 DAYS RATHER THAN EVERY 3-6 DAYS. THE PATIENT WAS COUNSELED TO SEEK RECOMMENDATIONS ON SITE ROTATIONS AS THE SAME 3-4 INCH AREA OF THE ABDOMEN WAS USED FOR 5 YEARS. CTS CONCLUDED THAT THE HYPERGLYCEMIA WAS CAUSED BY ADEQUATE PRIMING, INFREQUENT INFUSION SET REPLACEMENT, AND LACK OF SITE ROTATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING THE INSULIN PUMP. THE LIKELY CAUSE OF THE EVENT WAS DETERMINED TO BE USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282211 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization