BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233079 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48644
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BLANK DISPLAY ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 431 MG/DL. CUSTOMER STATED THAT SHE GAVE HERSELF HUMALOG. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE PUMP. CUSTOMER WILL CALL BACK WHEN SHE HAS THE PUMP TO TROUBLESHOOT. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL RIGHT NOW IS 214 MG/DL. CUSTOMER STATED THAT SHE LEFT HER PUMP IN HER CAR AND IS ON HER WAY TO CLASS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715454 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR