BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4150014 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34804
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 HAS BEEN HAVING LOWS LATELY. LAST NIGHT HER BLOOD GLUCOSE WAS 25 MG/DL AND SHE DOESN'T KNOW WHY. SHE WOKE UP IN THE MIDDLE OF THE NIGHT AND TREATED WITH FOOD. SHE HAS HAD THREE LOWS TODAY. CUSTOMER IS A BRITTLE DIABETIC. IN TROUBLESHOOTING, THE DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER FOLLOWS PROPER PRIMING METHODS. NO ANOMALIES WERE FOUND. CUSTOMER WAS ADVISED TO SPEAK TO HER DOCTOR ABOUT HER LOWS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627566 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention