BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3231219 · Received July 17, 2013

    Report

    Report Number
    2032227-2013-02954
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    July 1, 2012
    Report Date
    July 2, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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

    A PHONE CALL WAS MADE TO THE CUSTOMER IN ORDER TO FOLLOW UP ON A CALL SHE HAD MADE PREVIOUSLY REGARDING HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER DID NOT ANSWER, BUT SENT AN EMAIL STATING THAT HE EXPERIENCED UNEXPLAINED BLOOD GLUCOSE LEVELS MULTIPLE TIMES. THE CUSTOMER STATED THAT HE CALLED IN TO REPORT THE ISSUES, AND A WEEK LATER HE WAS IN THE HOSPITAL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332197 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723PNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization