BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4163713 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36589
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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 WAS HOSPITALIZED ON (B)(6) 2014 FOR HIGH BLOOD GLUCOSE. HER BLOOD GLUCOSE WAS 932 MG/DL WHEN ADMITTED. SHE WAS HAVING LOWS AS WELL. SHE WAS TREATED WITH AN INSULIN PEN. CUSTOMER HAD DIABETIC KETOACIDOSIS AND HYPERTENSION. THE DOCTOR STATED HE DOES NOT BELIEVE THE INSULIN PUMP WAS THE CAUSE OF THE HIGHS. CUSTOMER STATED SHE DOES NOT FEEL SAFE USING THE DEVICE. SHE IS WAITING FOR HER TRAINER TO GET BACK FROM SURGERY. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 102 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644811 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization