BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3855033 · Received June 9, 2014

    Report

    Report Number
    2531779-2014-16174
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    May 22, 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

    FOLLOW UP #1 SUBMITTED: 07/16/2014. 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. DEVICE EVALUATION: ON EXAMINATION, THE KEYPAD WAS INTACT WITHOUT DAMAGE. TESTING OF THE KEYPAD BUTTON FUNCTION WAS NOT POSSIBLE DUE TO AN UNRELATED ISSUE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION ON THE CONTACTS OF THE KEYPAD BUTTONS.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THE OK KEYPAD BUTTON WAS UNRESPONSIVE. THERE WAS NO REPORTED IMPACT TO THE PATIENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED KEYPAD BUTTON ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335520 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1