BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO DIABETIC PUMP

    MDR report key: 1962629 · Received January 12, 2011

    Report

    Report Number
    MW5018994
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    February 1, 2010
    Report Date
    January 6, 2011
    Manufacturer
    NIPRO DIABETIC SYSTEMS, INC.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INSULIN PUMP KEPT HAVING THE OCCLUSION ALARM TO KEEP GOING OFF. SENT MY BLOOD SUGAR INTO THE 1700'S SO I WAS HOSPITALIZED IN A COMA WHICH PUT ME ON A VENT FOR SEVERAL DAYS, BECAUSE OF NO DELIVERY OF INSULIN. THE DRS STATED THAT I MAY NOT COME OUT OF THE COMA! WENT THRU 4 PUMPS AND NONE OF THE PUMPS WORKED. THEY WERE ALSO MESSED UP. THE SPECIALIST FROM (B)(6) IS (B)(6). YOU CAN CONTACT HER AT (B)(4). DOSE OR AMOUNT: 2.0 BASEL RATE, FREQUENCY: HOURLY, ROUTE: THRU TUBING. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: DIABETES CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO DIABETIC PUMP INSULIN PUMP LZG NIPRO DIABETIC SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| O