BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2091547 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03461
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 24, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: NO ALARMS RELATED TO THE COMPLAINT WERE OBSERVED IN THE ALARM HISTORY. A CRACK WAS OBSERVED IN THE BATTERY COMPARTMENT. THE THREADS ON THE BATTERY CAP WERE OBSERVED TO BE STRIPPED. THE BATTERY CAP WAS UNABLE TO ESTABLISH AN ELECTRICAL CONNECTION, INABILITY TO POWER PUMP DUPLICATED. A TEST CAP WAS USED FOR TESTING PURPOSES. THE PUMP POWERS ON NORMAL WITH AUDIO, DISPLAY, AND BACKLIGHT WORKING. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP WAS PERFORMED AND THE PUMP WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. SOFTWARE VERSION: B2J, DATE OF MANUFACTURE: 6/2008.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE NOTICED THE PUMP WAS OFF AFTER TAKING A SHOWER. SHE NOTED THAT THE DISPLAY SCREEN WAS BLANK, AND THERE WERE NO TONES OR VIBRATIONS PRESENT. THE PATIENT DENIED EXPOSING THE PUMP TO WATER. SHE CONFIRMED THAT SHE WAS USING AN ENERGIZER ULTIMATE LITHIUM BATTERY. THE PATIENT STATED THAT SHE CHANGED THE BATTERY, BUT THE ISSUE DID NOT RESOLVE; SHE NOTED THAT THE PUMP DID NOT MAINTAIN TIME AND DATE SETTINGS WITH THE BATTERY CHANGE. SHE NOTED THERE WAS NO VISIBLE CORROSION IN THE BATTERY COMPARTMENT, AND THERE WAS NO STRUCTURAL DAMAGE TO THE BATTERY CAP OR TO THE BATTERY COMPARTMENT.

    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 60 YR