BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141567 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-32859
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. 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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES AND A FLATTENED BUTTON DOME SWITCH. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT, SHIFTED END CAP STICKER AND A STAINED END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BUTTON ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 198MG/DL. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621329 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR