BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4250920 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52581
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD SUGAR OF 445 MG/DL. THE CUSTOMER TREATED WITH AN INJECTION. DURING TROUBLESHOOTING, THE INFUSION SET WAS REMOVED FROM HIS BODY AND THE CANNULA WAS FOUND TO BE BENT. THE CUSTOMER STATED HE THOUGHT THE INFUSION SET HAD BEEN INSERTED INTO A CALLOUSED OR HARDENED AREA. INSERTION TECHNIQUES WERE DISCUSSED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736665 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR UNOMEDICAL INSULIN INFUSION SET