BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME REVEL INSUILN INFUSION PUMP

    MDR report key: 4123707 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-89259
    Date Received
    September 26, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATION CO
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED WITH BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED DISPLAY WINDOW CORNER, CRACKED BELT CLIP SLOT AT BATTERY TUBE THREADS AREA AND CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BUTTON ERROR ALARM ON HIS INSULIN PUMP. TROUBLESHOOTING FOUND ON EVENTS LEADING TO THE ALARM. CUSTOMER IS ADVISED TO REVERT TO HIS BACK-UP PLAN WHILE HIS PUMP IS BEING REPLACED. CUSTOMER STATED HE DID NOT HAVE A BACK-UP PLAN AND IS ADVISED TO CONTACT HIS PREVIOUS DOCTOR TO CREATE A BACK-UP PLAN. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602378 PARADIGM REAL-TIME REVEL INSUILN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATION CO MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR