BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3822432 · Received May 20, 2014

    Report

    Report Number
    2531779-2014-14330
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    May 5, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/05/2014WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS PEELED COMPLETELY OFF THE PUMP. ALL OF THE KEYPAD BUTTON CONTACTS WERE MISSING. CONTAMINATION WAS FOUND ON THE KEYPAD WIRE CONTACTS. ADDITIONALLY, THE PUMP BOOTED TO THE VERIFY SCREEN WITH A DIM PINK CONTRAST. THERE WAS ALSO A CRACK ALONG THE BATTERY COMPARTMENT THREADS. 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. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THERE WAS CONTAMINATION ON THE KEYPAD WIRE, A DIM AND DISCOLORED DISPLAY SCREEN, AND A CRACK IN THE BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 05/05/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299700 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1