BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4123491 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29632
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    (B)(4). 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

    CUSTOMER REPORTED SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE OF 400 MG/DL. CUSTOMER DID NOT HAVE ANY SYMPTOMS. CUSTOMER STATED THERE WERE NO ISSUES WITH THE INSULIN PUMP AND IT WAS WORKING FINE. NO FURTHER INFORMATION REPORTED. CUSTOMER ALSO REPORTED ISSUES WITH SENSOR READINGS. CUSTOMER STATED THE SENSOR ONCE READ SHE WAS 200 MG/DL AND BLOOD GLUCOSE WAS 400 MG/DL. CUSTOMER ALSO STATED SHE WAS TRYING TO CALIBRATE WHEN HER BLOOD GLUCOSE WAS HIGH AT 400 MG/DL. CUSTOMER WAS ADVISED, HOW TO PROPERLY CALIBRATED THE DEVICE TO GET ACCURATE READINGS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600292 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR