BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4142162 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33382
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    July 1, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 HAVING A HIGH BLOOD GLUCOSE OF 400 MG/DL. THE CUSTOMER STATED SHE HAD GIVEN HERSELF A BOLUS AND HER BLOOD GLUCOSE DID NOT DECLINE. SHE ALSO STATED HER CANNULA WAS NOT BENT. THE CUSTOMER'S BLOOD GLUCOSE WAS ABLE TO DECLINE AFTER SHE HAD CHANGED HER ITEMS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621989 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR