BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3241350 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11601
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    July 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/16/2013 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION. NO DAMAGE TO THE RUBBER KEYPAD WAS OBSERVED. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS RESPONDED PROPERLY; NO CORROSION WAS OBSERVED TO THE KEYPAD BUTTON CONTACTS. THERE WAS NO EVIDENCE OF MOISTURE WITHIN THE PUMP. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT, AFTER SWIMMING AND REPLACING THE BATTERY, THE KEYPAD BUTTONS WERE TEMPORARILY UNRESPONSIVE. IT WAS NOTED THAT, LATER, THE KEYPAD BUTTONS BEGAN TO RESPOND APPROPRIATELY. THE REPORTER ALSO STATED THAT THERE WAS MOISTURE BEHIND THE DISPLAY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340787 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR