BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3926481 · Received July 10, 2014

    Report

    Report Number
    2531779-2014-19541
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    June 17, 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED A TORN KEYPAD COVER AT THE OK BUTTON; THE UP AND OK KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONSIVE. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE BUTTON KEY CONTACTS. THE BATTERY COMPARTMENT WAS ALSO FOUND TO BE CRACKED ON THE THREADS AND THE TEXT ON THE DISPLAY SCREEN WAS FOUND TO BE DIM, FADED AND DISCOLORED. 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. INVESTIGATION REVEALED A TORN KEYPAD COVER AROUND THE OK BUTTON; THE UP AND OK KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONSIVE. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE BUTTON KEY CONTACTS. THE BATTERY COMPARTMENT WAS ALSO FOUND TO BE CRACKED ON THE THREADS AND THE TEXT ON THE DISPLAY SCREEN WAS FOUND TO BE DIM, FADED AND DISCOLORED. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404750 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1