BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3873352 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85788
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED REPORTING A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. SHE WAS STILL IN THE HOSPITAL AND WANTED TO TROUBLESHOOT FOR HIGH GLUCOSE. HAD ALREADY CHANGED 3 INFUSION SETS, AND WAS STILL EXPERIENCING HIGHS. HER BLOOD GLUCOSE LEVEL WAS 227 MG/DL. CUSTOMER ALSO HAD AN INFECTION IN HER FOOT. WHEN SHE WAS FIRST TAKEN TO THE EMERGENCY ROOM, HER BLOOD GLUCOSE LEVEL WAS 600 MG/DL. SHE FELT LETHARGIC, HAD SHAKING HANDS, FREQUENT URINATION, EXTREME THIRST, AND WAS NOT ABLE TO FUNCTION. SHE MENTIONED BEING IN AN ACCIDENT WHILE SHE WAS DRIVING. AT THE HOSPITAL, SHE WAS GIVEN MEDICATION FOR HER FOOT AND 20 UNITS OF INSULIN, CAUSING HER GLUCOSE LEVEL TO DROP TO 37 MG/DL, ALMOST PASSING OUT. SHE WAS STILL WEARING THE DEVICE WHEN SHE WAS GIVEN INSULIN. CUSTOMER GAVE HERSELF 8 UNITS OF INSULIN THROUGH BOLUS, BUT HER BLOOD GLUCOSE WENT UP. WHILE TESTING, SHE REMOVED THE INFUSION SET FROM HER BODY AND DISCOVERED THE CANNULA/NEEDLE WAS BENT AT THE TIP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349616 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization