BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3801091 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-84509
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    CUSTOMER STATED THAT HE WENT LOW AND HAD AN ACCIDENT. CUSTOMER STATED THAT THE SENSOR DID NOT ALERT HIM OF THE LOW BLOOD GLUCOSE. CUSTOMER LOST CONSCIOUSNESS. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 43 MG/DL. THE PARAMEDICS TRANSPORTED HIM TO THE HOSPITAL. CUSTOMER HAS BEEN EXPERIENCING LOWS IN THE AFTERNOON AND LATE EVENING. CUSTOMER VISITED HIS PHYSICIAN WHO DISCOVERED THAT ONE OF THE SETTINGS WAS TURNED OFF. THE CUSTOMER IS CALIBRATING TOO OFTEN, PHYSICIAN SUGGESTED TWICE A DAY. THE CURRENT BLOOD GLUCOSE READING IS 146 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277200 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization