BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3780755 · Received April 30, 2014

    Report

    Report Number
    2531779-2014-11903
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY ANIMAS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE UP BUTTON WAS FOUND TO BE INTERMITTENT WHILE THE CONTRAST BUTTON WAS FOUND TO BE UNRESPONSIVE. CONTAMINATION WAS FOUND UNDERNEATH THE CONTACTS FOR THE UP AND CONTRAST BUTTONS. UNRELATED TO THE KEYPAD ISSUE, THE PUMP BOOTED TO A DIM AND DISCOLORED DISPLAY SCREEN.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING THAT THE KEYPAD BUTTONS HAD BECOME UNRESPONSIVE. 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
    258880 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1