BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1926120 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02464
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 23, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP REBOOTED MULTIPLE TIMES W/O USER INTERVENTION. THE PT STATED THAT SHE CONFIRMED THE VERIFICATION SCREEN AND PRIMED THE PUMP AFTER EACH REBOOT; IMMEDIATELY AFTER PRIMING THE PUMP REBOOTED AGAIN. SHE EXAMINED THE BATTERY CAP AND NOTICED A SMALL BLACK PIECE THAT APPEARED TO BE THREADING PULLING AWAY FROM THE CAP. THE PT REPORTED THAT THE SPRING WAS ATTACHED TO THE CAP AND THE O-RING WAS INTACT. SHE STATED THAT THE BATTERY COMPARTMENT THREADS APPEARED NORMAL AND THERE WERE NO CRACKS NOTED ON PUMP CASING. THE PT REPLACED THE BATTERY CAP WITH A NEW ONE AND REPLACED THE BATTERY WITH SEVERAL OTHER NEW ONES; THE PUMP DISPLAYED NO EVIDENCE OF POWER (NO AUDIBLE TONES, NO DISPLAY, AND NO BACKLIGHT). SHE CONFIRMED THAT THE NEW BATTERY CAP WAS INTACT AND SECURED PROPERLY TO THE PUMP; POWER COULD NOT BE RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION IR1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR