BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3920871 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86568
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT PARAMEDICS WERE CALLED TO TREAT FOR LOW BLOOD GLUCOSE LEVELS ON (B)(6) OF 2014. CUSTOMER WAS HOME WHEN HIS WIFE TOOK HIS BLOOD GLUCOSE LEVEL AND FOUND IT LOW AT 32 MG/DL, WHILE HIS SENSOR WAS READING AT 66 MG/DL. CUSTOMER STATED HE SELF TREATED WITH APPLE JUICE, FISH AND A PIECE OF TOAST. PARAMEDICS TREATED CUSTOMER FOR LOW BLOOD GLUCOSE LEVELS. CUSTOMER BELIEVES OVEREATING AT DINNER CAUSED HIM TO GO LOW, BUT INACCURATE SENSOR READINGS PREVENTED HIM FROM TREATING PROPERLY PRIOR TO MEDICAL ASSISTANCE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 125 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398338 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization