BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5102974 · Received September 24, 2015

    Report

    Report Number
    2032227-2015-48695
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    September 5, 2015
    Report Date
    September 5, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 SHE HAD A BLOOD GLUCOSE LEVEL OVER 400 MG/DL ON THE MORNING OF THE CALL. CUSTOMER ALSO REPORTED THAT SHE HAD A BLOOD GLUCOSE LEVEL OF 480 MG/DL AND THE INSULIN PUMP DID NOT SHOW THAT ANY INSULIN HAD BEEN DELIVERED. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 555 MG/DL, WHICH WAS TREATED WITH A MANUAL INJECTION DURING THE CALL. THE CUSTOMER REPORTED THAT THE CANNULA WAS VERY BENT. THE CUSTOMER PERFORMED A SET CHANGE AND THE INSULIN PUMP INITIALLY FAILED, THEN PASSED THE HIGH PRESSURE TEST. THE INSULIN PUMP WAS NOT REPLACED OR RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633889 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other