BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP.

    MDR report key: 4212496 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-43419
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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

    THE CUSTOMER REPORTED HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT THE INSULIN PUMP DID NOT ALERT HER BLOOD GLUCOSE FOR HIGH AND LOW. CUSTOMER STATED RECEIVED CALIBRATION ERROR. CUSTOMER THINKS THAT IT WAS NOT PROGRAMMED CORRECTLY, CUSTOMER STATED HER BLOOD GLUCOSE WAS 505 MG/DL AND SHE DID NOT GET AN ALARM. CUSTOMER TREATED WITH INSULIN PUMP WITH EXTRA UNIT OF INSULIN OF THE 4 UNITS SHE WOULD HAVE NORMALLY DONE DUE TO HIGH BLOOD GLUCOSE. IT WAS FOUND THAT BASAL RATES AND BOLUS WIZARD ARE CORRECT. IT WAS ALSO FOUND IN THE ALARM HISTORY THAT THERE WAS 2 ALARMS FOR CHECK SETTINGS. NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684445 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP. OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR