BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4090434 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23118
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER HAVING REPORTED SENSOR ISSUES. CUSTOMER THE SENSOR HAS GIVEN TWO READING SINCE INSERTION. CUSTOMER HAS CALLED OVER THE PAST TWO WEEKS REQUESTING A NEW TRANSMITTER. THE LAST BLOOD GLUCOSE READING WAS 35 MG/DL. CUSTOMER TREATED WITH FOOD. CUSTOMER DECLINED TO TROUBLESHOOT FOR LOW BLOOD GLUCOSE. CUSTOMER REMOVED THE SENSOR AND THE TIP WAS NOT STRAIGHT. THE BLOOD GLUCOSE READING HAS INCREASED TO 63 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568309 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR