BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233425 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48517
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, A BROKEN BELT CLIP SLOT, A CRACKED RESERVOIR TUBE LIP, A CRACKED RESERVOIR TUBE AND A MISSING END CAP STICKER.

    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 THE CUSTOMER RECEIVED A BUTTON ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 139MG/DL. TROUBLESHOOTING OCCURRED. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713990 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR