BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4090387 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23071
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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

    THE CUSTOMER REPORTED THAT SHE HAD A BLOOD GLUCOSE OF 513 MG/DL, AND HAD DISCARDED HER LAST INFUSION SET, SO SHE COULD NOT USE HER INSULIN PUMP. THE CUSTOMER STATED THAT WHEN SHE HAD ORIGINALLY INSERTED THE INFUSION SET, SHE FELT PAIN, BUT THERE WAS NOT A BENT CANNULA OR OTHER OBVIOUS ISSE. IT WAS NOT POSSIBLE TO TROUBLESHOOT FOR THE CUSTOMER'S HIGH BLOOD GLUCOSE, AS SHE HAD DISCARDED THE INFUSION SET. THE CUSOTMER WAS ADVISED TO REVERT TO A BACK-UP PLAN UNTIL REPLACEMENT SETS WERE RECEIVED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568282 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR UNOMEDICAL INSULIN INFUSION SET