BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530 G INSULIN PUMP

    MDR report key: 4143393 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30113
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT HE NEEDED ASSISTANCE INSERTING THE SENSOR AND UPON INQUIRING FURTHER, IT WAS DISCOVERED THAT HE HAD BEEN HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. BLOOD GLUCOSE LEVEL WAS UNK AT TIME OF HOSPITALIZATION. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 287 MG/DL. AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603314 530 G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization