BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4223853 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46592
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    May 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE TEST TRANSMITTER WITH THE GLUCOSE SENSOR SIMULATOR COMMUNICATES PROPERLY TO PUMP. PUMP PROGRAMMED WITH BLOOD GLUCOSE VALUE ON THE GLUCOSE SENSOR SIMULATOR AND ALL REGISTERED PROPERLY ON THE SENSOR GRAPH NOTED. PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW AND CRACKED LCD WINDOW.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEY WERE EXPERIENCING AN INCREASE IN BLOOD GLUCOSE LEVELS. CUSTOMER ALSO STATED THEIR SENSORS WERE NOT CALIBRATING CORRECTLY, CAUSING THEM TO OVERCORRECT BOLUS AMOUNTS. CUSTOMER'S BLOOD GLUCOSE LEVELS WERE 276 MG/DL AT TIME OF REPORTING AND CUSTOMER IS TREATING WITH INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705252 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR