BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3982058 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89813
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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 GIVING HERSELF A BOLUS OF 14 UNITS OF INSULIN WHEN THE BLOOD GLUCOSE WAS 390 MG/DL AND DISCONNECTING AFTER TREATING. WHEN THE CUSTOMER CHECKED THE BLOOD GLUCOSE LEVEL AGAIN, IT WAS 496 MG/DL. THE CUSTOMER STATED THAT SHE BELIEVES THAT SHE DID NOT INSERT THE INFUSION SET CORRECTLY, BUT DECLINED TROUBLESHOOTING. THE CUSTOMER STATED THAT SHE WILL CHECK IF BLOOD GLUCOSE IS DECREASING AND CALL TO TROUBLESHOOT IF IT IS NOT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457309 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH A3751NAHJ

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR