BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4212445 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43292
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED OUT A FEW TIMES. CUSTOMER HAD NOT GOTTEN UP TO EAT. CUSTOMER WENT THROUGH A WHOLE BOX OF SENSORS. CUSTOMER STATED THAT THE READINGS ARE NOT EVEN CLOSE, THEY ARE 60 POINTS OFF. CUSTOMER STATED THERE ON A PREVIOUS SENSOR, THERE WAS EXCESSIVE BLEEDING. CUSTOMER STATED THAT THE SENSOR DID NOT STICK. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 42 MG/DL. CUSTOMER TREATED WITH FOOD AND GLUCOSE TABLETS. CUSTOMER WAS NOT ADMITTED AS AN INPATIENT FOR MEDICAL TREATMENT. CUSTOMER WAS ADVISED TO SPEAK TO HER HEALTH CARE PROFESSIONAL REGARDING THE LOW BLOOD GLUCOSE LEVELS. CUSTOMER WAS ALSO ADVISED TO MONITOR THE PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680618 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR