BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972072 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05073
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 18, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33, AND EXCESSIVE NO DELIVERY ALARM TEST. NO MOTOR ERROR ALARM NOTED. MOTOR PASSED MOTOR TEST. THE DEVICE WAS RECEIVED WITH SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 72 MG/DL. CUSTOMER DOES NOT RECALL ANY PREVIOUS SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE DEVICE TO ALARM. TROUBLESHOOTING WAS PERFORMED. CLEARED THE ALARM AND THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. CUSTOMER DOES NOT USE THE SENSOR FEATURE. CUSTOMER STATED SHE WAS UNABLE TO REWIND THE DEVICE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447277 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR