BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3933109 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86952
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READING WAS IN THE RANGE OF 200 TO OVER 400. SHE STATED THAT SHE HAS A STRESSFUL JOB AND THIS COULD HAVE BEEN THE CAUSE. THE PATIENT SPOKE WITH HER EDUCATOR ABOUT THE ISSUE AND THAT SHE WILL GO BACK ON THE DEVICE WHEN SHE GOES ON VACATION. PRIOR TO THE EVENT, THE CUSTOMER REPORTED THAT THERE ARE DISCREPANCIES WITH A 30 POINT DIFFERENCE BETWEEN THE SENSOR READING AND HER ACTUAL BLOOD GLUCOSE LEVEL. SHE IS PLANNING ON MEETING WITH HER PHYSICIAN ABOUT THE ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411180 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR