BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4974671 · Received August 5, 2015

    Report

    Report Number
    2032227-2015-25205
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 23, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO A CORRODED KEYPAD. THERE WAS NO BUTTON ERROR ALARM DURING TESTING. THE PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A MINOR SCRATCHED LCD WINDOW, A SCRATCHED RESERVOIR TUBE WINDOW, A CRACKED BELT CLIP SLOT, A CRACKED RESERVOIR TUBE LIP, AND A MISSING END CAP STICKER. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN TO REPORT THAT HER INSULIN PUMP HAD A BUTTON ERROR ALARM WHILE SHE WAS TRYING TO CHECK HER BLOOD GLUCOSE LEVEL AND PROGRAM IT INTO THE PUMP. HER BLOOD GLUCOSE LEVEL WAS 99 MG/DL. CUSTOMER STATED THAT SHE WAS STUCK BETWEEN THE PILLOW. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515747 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR