BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4170415 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37931
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE. SHE STATED HER BLOOD GLUCOSE WAS RISING THROUGHOUT THE DAY. THE CUSTOMER'S BLOOD GLUCOSE WAS 532 MG/DL. TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE FOUND THE CUSTOMER HAD SYMPTOMS OF HIGH BLOOD GLUCOSE SUCH AS FEELING QUEASY, LETHARGIC, AND TIRED. TROUBLESHOOTING FOR THE INSULIN PUMP FOUND THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL AND INSULIN WAS ABLE TO EXIT FROM THE TUBING. THE CUSTOMER ALSO STATED HER CANNULA WAS NOT BENT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650896 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR