BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4110656 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27956
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH A MOTOR ERROR ALARM DURING THE REWIND DUE TO A CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM THE DISPLACEMENT TEST AND VERIFY THE NO DELIVERY ALARM DUE TO THE MOTOR ERROR ALARM. THE PUMP ALSO HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, AND CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE PATIENT THAT THEIR INSULIN PUMP IS GIVING EXCESSIVE NO DELIVERY ALARMS AND A MOTOR ERROR. THE PATIENT'S BLOOD GLUCOSE LEVEL IS UNKNOWN. TROUBLE SHOOTING WAS CONDUCTED. DEVICE IS BEING RETURNED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590184 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR