BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1790108 · Received August 2, 2010

    Report

    Report Number
    2531779-2010-00818
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    May 17, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO ANIMAS FOR INVESTIGATION. IF THE PUMP IS RETURNED, AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. THERE WAS NO ALLEGATION OF A PUMP MALFUNCTION, AND THE REPORTER CONTACTED ANIMAS TO REVIEW THE PUMP FOR POTENTIAL ISSUES. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS SWEATING AND FELL UNCONSCIOUS, REQUIRING TREATMENT WITH GLUCOSE TABLETS AND SODA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention