BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1894388 · Received November 5, 2010

    Report

    Report Number
    2531779-2010-02109
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HOSPITALIZED FOR HYPERGLYCEMIA AND DKA. IT WAS SIMULTANEOUSLY REPORTED THAT NO HISTORICAL DATA WAS RECORDED IN THE PUMP FOR (B)(6) 2010 ALTHOUGH THE PT ALLEGEDLY WORE IT UNTIL THE (B)(6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 109 YR Hospitalization