BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3171207 · Received June 14, 2013

    Report

    Report Number
    2032227-2013-02480
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    August 13, 2012
    Report Date
    August 13, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD UNEXPLAINED HIGH BLOOD GLUCOSE, WENT TO THE EMERGENCY ROOM WERE SHE WAS TREATED AND RELEASED. CUSTOMER BLOOD GLUCOSE READING AT THE TIME OF THE EMERGENCY ROOM VISIT WAS UNKNOWN. CUSTOMER STATED THAT IN (B)(6) 2012 SHE FELLED AND WAS INJURED. CUSTOMER STATED THAT SHE WAS IN REHAB FOR 4 MONTHS AND SINCE THEN HER MEMORY WAS AFFECTED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271163 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization