BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3873321 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85775
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    IT WAS REPORTED BY THE CUSTOMER THAT SHE HAD BEEN HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS IN THE MONTH OF FEBRUARY, BUT CANNOT RECALL SPECIFIC DATE. BLOOD GLUCOSE LEVEL WAS 583 MG/DL AT TIME OF HOSPITALIZATION. CUSTOMER DOES NOT RECALL EVENTS LEADING TO EVENT. ADVISED TO TROUBLESHOOT INSULIN PUMP BUT CUSTOMER DECLINED STATING PUMP WAS FUNCTIONING PROPERLY. ADVISED CUSTOMER TO MONITOR SYSTEM. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349131 530G INSULIN PUMP OYZ OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization