BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4241573 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50032
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD NORMAL OPERATING CURRENTS AND NO BATTERY ALARMS WERE NOTED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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

    IT WAS REPORTED THAT CUSTOMER EXPERIENCED A FAILED BATTERY TEST AND A BATTERY OUT LIMIT. THE CUSTOMER'S BLOOD GLUCOSE WAS 200 MG/DL. ADVISED CUSTOMER THAT THEIR INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED THE CUSTOMER TO REVERT TO THEIR BACK-UP PLAN. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722106 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR