BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2081594 · Received May 9, 2011

    Report

    Report Number
    2531779-2011-03217
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    March 2, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE DOWN ARROW KEYPAD BUTTON HAS BEEN INTERMITTENTLY UNRESPONSIVE FOR (B)(6). HE NOTED THAT THE PUMP IS OCCASIONALLY DROPPED OR BUMPED. THE PATIENT CONFIRMED THAT THE RUBBER KEYPAD IS INTACT; DENIED EXPOSING THE PUMP TO WATER OR CLEANING PRODUCTS; AND STATED THAT HE WEARS THE PUMP CLIPPED TO HIS BELT. THE PATIENT CHOSE TO CONTINUE USING THE PUMP AT THE TIME OF THE COMPLAINT WITH NO FURTHER REPORTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 61