BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4142076 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33331
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE EXPERIENCED HIGH BLOOD GLUCOSE OF 441 MG/DL, 458 MG/DL, AND 466 MG/DL. CUSTOMER WAS ADVISED THAT SHE NEEDS TO ADMINISTER A BOLUS SHOT. CUSTOMER STATES SHE SOMETIMES ACCIDENTALLY GIVES HERSELF A BOLUS SHOT WHEN ASLEEP DUE TO HER NOT KNOWING HOW TO CANCEL BOLUS DELIVERY. CUSTOMER WAS INSTRUCTED ON HOW TO CANCEL BOLUS DELIVERY. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621295 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR