BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4811230 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61460
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    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

    CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP HAS A BLANK DISPLAY AFTER BATTERY CHANGE. CUSTOMER'S BLOOD GLUCOSE READING WAS 65 MG/DL. CUSTOMER STATED THAT THERE IS SOMETHING WRONG WITH THE SOFTWARE THAT THE COMBINATION OF THE BUTTONS HE PRESSED WITH THE THRESHOLD SUSPEND CAUSED THE PUMP'S SOFTWARE TO FAIL. CUSTOMER DECLINED TO CONTINUE TROUBLESHOOTING FOR THE BLANK DISPLAY AND REFUSED THE REPLACEMENT BATTERY CAP. PRODUCT IS NOT BEING RETURNED OR REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356818 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR