BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3954138 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-88105
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED ABOUT 4 MONTHS PRIOR. THE BLOOD GLUCOSE READING WAS OVER 600 MG/DL. THE CUSTOMER STATED THAT SHE COMPLETELY BLAMED THE DENTIST BECAUSE IT HAPPENED AFTER VISITING HIM BUT THAT SHE LOVES HER INSULIN PUMP. SHE DECLINED TROUBLESHOOTING. THE CUSTOMER REPORTED THAT SHE WAS GIVING HERSELF INSULIN AND HER BLOOD GLUCOSE LEVELS WOULD NOT COME DOWN. SHE BELIEVED THAT HER DENTIST DID SOMETHING TO CAUSE THE ISSUE. THE EMERGENCY ROOM VISIT WAS CAUSED BY DEHYDRATION AND IMBALANCED ELECTROLYTES. THE CUSTOMER WAS TREATED AT THE HOSPITAL WITH INSULIN AND FLUIDS AND WAS WATCHED FOR 3 DAYS. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EMERGENCY ROOM CALL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430955 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization