BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6093297 · Received November 10, 2016

    Report

    Report Number
    2032227-2016-41100
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 5, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 400 MG/DL. THE CUSTOMER WAS TREATED FOR THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS. THE CUSTOMER STATES THAT THEY RECEIVE A NO DELIVERY ALARM AFTER A BOLUS. CUSTOMER WOULD JUST PRESS THE RESUME BUTTON REPEATEDLY UNTIL THE BOLUSES FINISHED DELIVERING. THE CUSTOMER WAS ASSISTED WITH TROUBLE SHOOTING AND WAS INFORMED TO REWIND THEIR INSULIN PUMP AND REINSERT THE RESERVOIR. THE CUSTOMER DID NOT RETURN THE PRODUCT BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745989 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other