BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3110582 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06320
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 18, 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 BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION - (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE 'OK','UP','DOWN' AND 'CONTRAST' BUTTONS. REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS. CONTAMINATION WAS PRESENT UNDER THE CONTACTS OF ALL BUTTONS. UNRELATED TO THIS COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED. T OPENING OF BATTERY CHAMBER EXTENDING DOWN TO THE PRIMARY SEAL. THE RETURNED BATTERY CAP WAS ABLE TO FULLY TIGHTEN UNTIL O-RING WAS SEATED AND CAP WAS FLUSH WITH THE PUMP CASE. NO POWER LOSS OR MOISTURE INGRESS WAS NOTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS ARE 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
    213121 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1