BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3073654 · Received April 23, 2013

    Report

    Report Number
    2032227-2013-01506
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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

    THE CUSTOMER CALLED BECAUSE HER BLOOD GLUCOSE LEVELS HAD BEEN RUNNING LOW ALL MORNING, AND SEE HAS NOT BEEN FEELING WELL. THE CUSTOMER STATED THAT HER LAST BLOOD GLUCOSE READING WAS 47 MG/DL AND SHE WANTS TO GO TO THE EMERGENCY ROOM. THE CUSTOMER TREATED WITH ORANGE JUICE, BUT STATED THAT SHE WAS STILL NOT FEELING WELL. THE CUSTOMER STATED THAT SHE WOULD CALL BACK LATER BECAUSE, SHE DID NOT FEEL WELL, AND DISCONNECTED THE CALL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173883 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization