BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4308984 · Received December 9, 2014

    Report

    Report Number
    2032227-2014-63439
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    August 28, 2014
    Report Date
    November 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE HAD A STROKE AT THE END OF (B)(6) 2014. A FEW DAYS PRIOR TO THE STROKE, CUSTOMER WAS EXPERIENCING NAUSEA AND BAD HEADACHES. SHE WAS VISITING A FRIEND IN THE HOSPITAL WHEN SHE NOTICED HER FACE APPEARED DROOPY. SHE WENT TO EMERGENCY ROOM. HER BLOOD GLUCOSE WAS 565 MG/DL AND HER BLOOD PRESSURE WAS 200/168. SHE ALSO HAD A THYROID PROBLEM. THE DOCTOR STATED SHE MUST HAVE HAD A SEIZURE, POSSIBLY FROM THE HIGH BLOOD GLUCOSE OR THE BLOOD PRESSURE. CUSTOMER HAD A BLOOD CLOT IN HER BRAIN. SHE STATED SHE FELT THE BLOOD CLOT CAUSED THE HIGH BLOOD GLUCOSE AND BLOOD PRESSURE. CUSTOMER WAS HOSPITALIZED FOR SIX DAYS. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. SHE STATED THE INSULIN PUMP IS WORKING FINE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796093 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization