BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210536 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43323
    Event Type
    Injury
    Date Received
    October 25, 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

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSIONS 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 WAS CALLING IN JUST TO LINK THE SENSOR AND INSULIN PUMP. DURING THE CALL, THE CUSTOMER SEEMED INCOHERENT. THE CUSTOMER DID NOT UNDER THE QUESTIONS SHE WAS BEING ASKED AND ONLY REPEATED THEM. PARAMEDICS WERE CALLED OUT. PARAMEDICS STATED CUSTOMER'S BLOOD GLUCOSE HAD DROPPED TO 20 MG/DL. CUSTOMER WAS GIVEN FOOD AND THEY DID NOT ANTICIPATE TAKING HER TO THE HOSPITAL. CUSTOMER CALLED BACK AND WANTED TO KNOW WHY HER SENSOR DID NOT ALERT HER WHEN HER BLOOD GLUCOSE WAS 505 MG/DL AND 26 MG/DL. THE TRANSMITTER WAS NOT PROGRAMMED CORRECTLY TO THE DEVICE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680483 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention