BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4802332 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-59989
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    April 26, 2015
    Report Date
    May 7, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT ON (B)(6) 2015 SHE WOKE UP AND HER BLOOD GLUCOSE WAS 189 MG/DL AND AFTER EATING, IT STARTED CLIMBING AND HAD TO GO TO THE HOSPITAL. SHE TREATED WITH A MANUAL INJECTION AND CHANGED THE SET ON THE WAY TO THE HOSPITAL. SHE FOUND THE CANNULA WAS BENT. BLOOD GLUCOSE VALUE AT THE TIME OF ADMISSION WAS 417 MG/DL. SHE EXPERIENCED NAUSEA, VOMITING AND STOMACH PAINS. SHE WAS TREATED WITH IV FLUIDS. SHE STATED THAT ONE OF THE TESTS FOR DIABETIC KETOACIDOSIS CAME OUT HIGH. CURRENT BLOOD GLUCOSE READING IS 133 MG/DL. THE CUSTOMER ALSO REPORTED SHE WAS IN AN AUTOMOBILE ACCIDENT ON 5/6/2015. SHE WAS STOPPED AND GOT REAR ENDED AND WAS HOSPITALIZED. BLOOD GLUCOSE WAS 111 MG/DL. THE INSULIN PUMP HAD NO VISIBLE DAMAGE. THE DRIVE SUPPORT CAP IS NORMAL. IT PASSED THE DISPLACEMENT AND SELF TESTS. SHE ALSO MENTIONED RECEIVING A NO DELIVERY ALARM WHICH WAS RESOLVED BY AN INFUSION SET CHANGE. BLOOD GLUCOSE WAS 212 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345665 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization