BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3972234 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88647
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    THE CUSTOMER REPORTED THAT THERE ARE DISCREPANCIES BETWEEN HIS BLOOD GLUCOSE LEVEL AND HIS SENSOR READINGS. PRIOR TO THE EVENT, THE PATIENT WAS ATTEMPTING TO CALIBRATE AND HE RECEIVED A CALIBRATION ERROR. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 420 MG/DL. THE CUSTOMER WAS DRIVING AT THE TIME OF THE CALL. HE DIDN'T WANT TO TROUBLESHOOT AND DECIDED TO GO HOME. THE CURRENT BLOOD GLUCOSE READING IS 350 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447543 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR