BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3253021 · Received July 29, 2013

    Report

    Report Number
    2032227-2013-03206
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    September 25, 2012
    Report Date
    July 3, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. CUSTOMER BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 20 MG/DL. CUSTOMER STATED THAT SHE REMEMBERS HAVING A SEIZER AND HER DAUGHTER FOUND HER UNCONSCIOUS ON THE FLOOR AND CALLED THE PARAMEDICS. CUSTOMER ALSO STATED THAT IN (B)(6) 2013 SHE HAD A CAR ACCIDENT DUE TO LOW BLOOD GLUCOSE. THE LOW BLOOD GLUCOSE WAS 25 MG/DL WHEN PARAMEDICS PULLED HER OUT OF THE CAR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352325 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization