BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3920860 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86555
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. CUSTOMER STATED THAT HE WAS ON HIS WAY HOME WHEN HIS BLOOD GLUCOSE READINGS WENT LOW AND HE GOT INTO A CAR ACCIDENT. CUSTOMER WAS HOSPITALIZED WITH A BLOOD GLUCOSE READING OF 25 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 170 MG/DL. CUSTOMER ALSO REPORTED RECEIVING A LOST SENSOR ALARM. TROUBLESHOOTING WAS PERFORMED AND NO DAMAGE TO THE DRIVE SUPPORT CAP WAS NOTED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398435 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization