BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3655579 · Received March 3, 2014

    Report

    Report Number
    2531779-2014-05808
    Event Type
    Malfunction
    Date Received
    March 3, 2014
    Date of Event
    January 10, 2014
    Report Date
    February 7, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDED EVALUATION CONCLUSIONS THAT WERE NOT INCLUDED IN THE INITIAL SUPPLEMENTAL REPORT IN ERROR. ADDITIONALLY, THE 510K NUMBER FOR THIS PRODUCT IS: K032257.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 04/16/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/26/2014 WITH THE FOLLOWING FINDINGS: TESTING CONFIRMED THAT THE KEYPAD BUTTONS WERE RESPONSIVE TO BUTTON PRESSES. THE KEYPAD HAD NO VISIBLE SIGN OF DAMAGE. CONTAMINATION WAS PRESENT UNDERNEATH THE CONTACTS OF ALL BUTTONS. UNRELATED TO THE KEYPAD COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED. THERE WAS NO ISSUE WITH A LOSS OF POWER AND NO EVIDENCE OF MOISTURE DAMAGE IN THE BATTERY COMPARTMENT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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) 2014, A DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT THE KEYPAD WAS MISSING/PEELING/TORN AND THAT THE BUTTONS WERE UNRESPONSIVE. THIS COMPLAINT IS BEING REPORTED BECAUSE IT WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126853 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1