BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1982628 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00261
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 16, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE DISTRIBUTOR, THE PUMP HAS A BLANK SCREEN. THE PT REPORTEDLY REPLACED THE BATTERY AND THE ISSUE PERSISTED. THE PT INDICATED THAT THERE WERE NO CRACKS IN BATTERY CASING OR SIGNS OF RUST IN THE BATTERY CAP OR PUMP. THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1