BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4862661 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-67815
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 16, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE HAD AN ISSUE WHERE HER PUMP ALARMS IN THE MIDDLE OF THE NIGHT THAT SHE IS LOW OR HIGH. CUSTOMER STATED THAT THE BACKLIGHT DOES NOT WORK. CUSTOMER WAS ASSISTED WITH TURNING THE BACKLIGHT ON AND SHE WAS ABLE TO DO IT. CUSTOMER STATED THAT THERE ARE TIMES WHEN HER BLOOD GLUCOSE DROPS AND IT ALARMS HER AND SUSPENDS IN THE MIDDLE OF THE NIGHT. CUSTOMER CHECKS HER BLOOD GLUCOSE AND DRINKS EITHER SODA OR JUICE AND TREATS IT. CUSTOMER THEN UNSUSPENDS THE PUMP AND 3 MINUTES LATER IT GOES BACK INTO SUSPEND AND ALARMS. CUSTOMER STATED THAT SHE CAN'T GO BACK TO SLEEP EVEN THOUGH SHE TREATED THE LOW. CUSTOMER STATED THAT WHEN SHE WAKES UP, HER BLOOD GLUCOSE IS OVER 400 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407056 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other