BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2062670 · Received April 11, 2011

    Report

    Report Number
    2531779-2011-02497
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    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 DEVICE WAS NOT RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE CONDUCTED AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE USER GUIDE STATES THAT TO AVOID THE RISK OF DIABETIC KETOACIDOSIS (DKA) OR VERY HIGH BLOOD GLUCOSE (BG), THE USER MUST BE PREPARED TO GIVE HIM/HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT STATED THAT THE PUMP SCREEN WOULD GO BLANK AND THE PUMP WOULD LOSE POWER. HE ALSO REPORTED THAT THE SCREEN APPEARED HAZY UNDER THE DISPLAY LENS. HE STATED THAT HE REMOVED THE BATTERY CAP PRIOR TO CALLING ANIMAS AND REPORTS HE WAS ABLE TO TIGHTEN THE BATTERY CAP TO RESISTANCE WITH A COIN. THE THREADS ARE REPORTEDLY INTACT AND THE CAP WAS 2 MONTHS OLD. THERE WERE NO VISIBLE CRACKS IN THE BATTERY COMPARTMENT. THE PT SAID HE HAD AN ELEVATED BLOOD GLUCOSE LEVEL OF 350 MG/DL WITH KETONES PRESENT AND SHORTNESS OF BREATH ABOUT A WEEK PRIOR TO CONTACTING ANIMAS. HE SAID HE TREATED THE BLOOD GLUCOSE LEVEL WITH THE PUMP AND WAS ABLE TO LOWER HIS BLOOD GLUCOSE LEVEL TO 140 MG/DL. HE ALSO REPORTED THAT THE PUMP LOST PRIME THE EVENING PRIOR TO CALLING ANIMAS BUT THE PUMP DID NOT LOSE POWER. HE REPORTED THAT HIS BLOOD GLUCOSE LEVEL THE MORNING PRIOR TO CALLING ANIMAS WAS 210 MG/DL AND DID NOT REPORT ANY SYMPTOMS. HE STATED HE DOES HAVE A BACKUP PLAN FOR INSULIN DELIVERY AND THE ANIMAS REP ADVISED HIM TO USE HIS BACKUP PLAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening