BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4663809 · Received April 7, 2015

    Report

    Report Number
    3004209178-2015-47128
    Event Type
    Injury
    Date Received
    April 7, 2015
    Date of Event
    March 21, 2015
    Report Date
    March 21, 2015
    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 REPORTED SHE EXPERIENCED SEIZURES WAS IN A COMA FOR THREE MONTHS. CUSTOMER ALSO REPORTED THAT HEW BLOOD GLUCOSE WENT DOWN TO 54 MG/DL WHEN SHE WOKE UP, EVEN THOUGH SHE ATE WELL THE DAY BEFORE. SHE THINKS HER RATES NEED TO BE ADJUSTED. CUSTOMER DID NOT BELIEVED THE INSULIN PUMP NEEDED TO BE TROUBLESHOOTED. SHE REQUESTED ASSISTANCE WITH CHANGING HER INFUSION SET SINCE IT WAS HER FIRST CHANGE AFTER TRAINING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229868 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization