BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3951734 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21029
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT AN OCCLUSION DUE TO HIGH FORCE WAS RECORDED. THE PUMP WAS UNABLE TO COMPLETE FULL TESTING OF THE COMPLAINT DUE TO THE MOISTURE INGRESS. VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED EXTENDING FROM THE THREADS TO THE CASE SEAL. THE PUMP CASE WAS ALSO FOUND TO BE CRACKED IN THE LOWER RIGHT CORNER BETWEEN THE DISPLAY LENS AND THE CASE SEAL. CORROSION WAS FOUND IN THE BATTERY COMPARTMENT AND ON THE BATTERY CAP SPRING. A LEAK TEST WAS PERFORMED AND LEAKS WERE FOUND AT THE BATTERY COMPARTMENT CRACK AND THE PUMP CASE CRACK. THE PUMP CASE WAS REMOVED AND CORROSION WAS FOUND ON THE FORCE SENSOR FLEX CABLE AND CONNECTOR. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE UP ARROW, DOWN ARROW, AND CONTRAST KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE OK KEYPAD BUTTON WAS FOUND TO BE UNRESPONSIVE. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS FADED AND DISCOLORED. EVIDENCE OF THE COMPLAINT WAS OBSERVED IN THE PUMP HISTORY BUT WAS NOT ABLE TO BE ADEQUATELY INVESTIGATED. 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 PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED A BATTERY COMPARTMENT CRACK AND DISPLAY WAS FADED AND DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430554 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR