BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4161884 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36086
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    CUSTOMER REPORTED A HOSPITALIZATION EVENT FOR HIGH BLOOD GLUCOSE. THE CUSTOMER STATED SHE WAS FEELING SICK WITH A HEADACHE AND HAD A TINGLING SENSATION IN HER ARM PRIOR TO BEING HOSPITALIZED. SHE ALSO REPORTED FEELING NAUSEOUS AND FAINT PRIOR TO BEING HOSPITALIZED. SHE STATED THE EMERGENCY MEDICAL SERVICES WAS CALLED AND IT WAS FOUND THAT HER INSULIN PUMP WAS NOT CLIPPED ALL THE WAY IN. DATE OF HOSPITALIZATION WAS (B)(6) 2014. BLOOD GLUCOSE AT THE TIME OF ADMISSION WAS 500 MG/DL. THE CUSTOMER STATED SHE WAS NOT TREATED IN THE HOSPITAL. THE CUSTOMER'S DAUGHTER TREATED HER HIGH BLOOD GLUCOSE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640498 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization