BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2234018 · Received September 6, 2011

    Report

    Report Number
    2531779-2011-06482
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: MOISTURE WAS OBSERVED IN THE BATTERY COMPARTMENT. THE PUMP POWERED ON APPROPRIATELY. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT OVERHEATING. THE PUMP WAS OPENED AND NO INTERNAL MOISTURE DAMAGE WAS FOUND. THE POWER CIRCUIT WAS TESTED FOR INTERMITTING CONNECTIONS AND NO DEFECTS WERE FOUND. THE COMPLAINT OF OVERHEATING WAS UNABLE TO BE CONFIRMED OR DUPLICATED DURING TESTING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE WOKE UP TO FIND HER PUMP WAS HOT TO THE TOUCH. THE PATIENT REPORTEDLY CHANGED THE BATTERY AT THAT TIME AND THE PUMP WAS STILL WARM. THE PATIENT REPORTED THAT THERE WAS SOMETHING BROWN AT THE BOTTOM OF THE BATTERY COMPARTMENT; THE PATIENT DENIED THE PUMP GETTING WET.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR