BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2170388 · Received July 21, 2011

    Report

    Report Number
    2531779-2011-05077
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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 KEYPAD BUTTONS BECAME INTERMITTENTLY UNRESPONSIVE THREE DAYS AGO. HE STATED THAT HE WAS ABLE TO REBOOT THE PUMP AND THE BUTTONS WOULD RESPOND AGAIN, BUT TODAY THE KEYPAD BUTTONS ARE NOT RESPONDING AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR