BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4920186 · Received July 16, 2015

    Report

    Report Number
    3004209178-2015-74858
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 21, 2015
    Report Date
    June 26, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEIR INSULIN PUMP ALARMED NO DELIVERY MULTIPLE TIMES. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 53 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT THEY AND DO NOT WANT TO RETURN THE RESERVOIR BACK FOR ANALYSIS. THE DO NOT WANT TO TROUBLE SHOOT THE ISSUE AT THE TIME OF THE CALL CUSTOMER WAS ADVISED TO CHANGE THEIR RESERVOIR SET AS SOON AS POSSIBLE. THE CUSTOMER DID NOT RETURN THE PRODUCT BACK FOR ANALYSIS. THE CUSTOMER WAS SENT REPLACEMENT SENSORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464201 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR