BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3132444 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07165
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 30, 2013
    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

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 06/26/2013 WITH THE FOLLOWING RESULTS: UNABLE TO DUPLICATE UNRESPONSIVE KEYPAD. TESTING CONFIRMED THE 'UP', 'DOWN', 'OK' AND 'CONTRAST' BUTTONS ARE RESPONSIVE TO BUTTON PRESSES AND ARE FUNCTIONAL. THE BUTTONS HAVE SPRING BACK AND CLICK. THE KEYPAD HAS NO VISIBLE SIGN OF DAMAGE. REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS. NO CONTAMINATION OR OTHER ANOMALIES FOUND. PUMP WAS OPENED TO CHECK CONDITION OF THE KEYPAD FLEX AND CONNECTOR. THE KEYPAD FLEX IS FIRMLY SEATED IN CONNECTOR WITH NO SIGNS OF DAMAGE OR CONTAMINATION VISIBLE ON FLEX OR CONNECTOR. OBSERVED THE BOLUS BUTTON COVER AND PLUG ARE DETACHED FROM THE PUMP, EXPOSING THE INTERNAL CONTACT. 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.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013 AND REPORTED THE AUDIO BOLUS BUTTON WAS UNRESPONSIVE. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE BUTTON RESPONSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237194 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1