BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974262 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88893
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE ACT AND ESC BUTTONS DID NOT RESPOND DUE TO FLATTEN BUTTON DOME SWITCHES. UNABLE TO VERIFY THE MOTOR ERROR ALARM DUE TO THE UNRESPONSIVE BUTTONS. HOWEVER, THE MOTOR PASSED THE MOTOR TEST. THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT, AND BROKEN RESERVOIR TUBE LIP.

    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.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A MOTOR ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 400 MG/DL. TROUBLESHOOTING WAS DONE AND ADVISED CUSTOMER ON PROPER USE OF INSULIN PUMP. CUSTOMER WAS AT THE DOCTOR'S OFFICE AT TIME OF ALARM; HIS BLOOD GLUCOSE LEVEL WAS 481 MG/DL. ADVISED CUSTOMER TO RETURN THE PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449773 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR