BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3972359 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88704
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    May 22, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    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

    CUSTOMER REPORTED HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE READINGS BELOW 70 MG/DL. CUSTOMER REPORTED THAT SHE TREATED WITH CANDY AND FELT FINE AT THE TIME. CUSTOMER THEN WENT TO HER DOCTOR'S APPOINTMENT AND FELT LIKE SHE WAS UNABLE TO SPEAK AND BARELY WALK. WHEN THE CUSTOMER RETURNED HOME SHE WAS UNABLE TO SEE ANYTHING AND THE PARAMEDICS WERE CALLED AND SHE WAS TAKEN TO THE HOSPITAL. ACCORDING TO THE DOCTOR THE LOW BLOOD GLUCOSE READINGS CAUSED A STROKE AND THE CUSTOMER WAS HOSPITALIZED FOR TWO AND HALF DAYS. BLOOD GLUCOSE READINGS ARE UNKNOWN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447529 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization