BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4233753 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-49207
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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

    IT WAS REPORTED THAT THE CUSTOMER REQUIRED MEDICAL INTERVENTION DUE TO LOW BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS IN THE 40 MG/DL RANGE. THE CUSTOMER STATED THAT HE WAS TREATED AT HOME AND THE ISSUE WAS RESOLVED. HE REPORTED THAT THE PERCEIVED CAUSE OF LOW BLOOD GLUCOSE LEVELS WAS A COMBINATION OF EXERCISE AND A MISCALCULATION OF CARBOHYDRATES. HE STATED THAT WHILE HE WAS SLEEPING WHEN HIS GIRLFRIEND ATTEMPTED TO ASSIST HIM AND HE WAS NOT COOPERATING, LEADING HER TO CALL EMERGENCY MEDICAL SERVICES FOR ASSISTANCE. HE REPORTED THAT HE WAS ABLE TO STABILIZE HIS BLOOD GLUCOSE LEVELS UPON TREATMENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714603 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention