BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2221621 · Received August 24, 2011

    Report

    Report Number
    2531779-2011-06168
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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: THE PUMP POWERS ON NORMALLY WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. A REVIEW OF THE PUMP HISTORY INDICATED THAT REBOOTING HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. TESTING COULD NOT BE ADEQUATELY COMPLETED DUE TO AN UNRESPONSIVE DOWN ARROW KEYPAD BUTTON. EVALUATION REVEALED MOISTURE AND CORROSION INSIDE THE BATTERY COMPARTMENT, AND INTERNAL MOISTURE DAMAGE INSIDE THE PUMP.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    THE PATIENT REPORTED THAT THE PUMP HAD INTERMITTENT POWER; THE PUMP WOULD OCCASIONALLY HAVE THE VERIFICATION SCREEN AND OTHER TIMES WOULD HAVE THREE COLOR LINES ON THE DISPLAY BUT THE POWER WOULD GO OUT IN A FEW MINUTES. AT THE TIME OF THE CALL, THE PATIENT REPORTED THAT THE PUMP WOULD MAKE INTERMITTENT CHIRPING BUT WOULD NOT REBOOT OR GO TO VERIFY SCREEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR