BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5981779 · Received September 27, 2016

    Report

    Report Number
    2032227-2016-24267
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    August 22, 2016
    Report Date
    October 6, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH NO BUTTON RESPONSE DUE TO A FLATTENED UP KEYPAD DOME. THE PUMP HAD MINOR SCRATCHES ON THE LCD WINDOW, A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, AND A CRACKED RESERVOIR TUBE LIP. UNABLE TO PERFORM THE FUNCTIONAL TESTING DUE TO THE KEYPAD ANOMALY. THE KEYPAD CONNECTOR WAS FOUND CLOSED PROPERLY DURING VISUAL INSPECTION.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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

    THE CUSTOMER REPORTED VIA TELEPHONE CALL THAT THE BLOOD GLUCOSE RAN HIGH. THE BLOOD GLUCOSE READING WAS 359 MG/DL. SHE STATED THAT THE BLOOD GLUCOSE WAS HIGH DUE TO STRESS. IT WAS ALSO REPORTED THAT THE MAX BASAL RATE COULD NOT BE CHANGED. THE CUSTOMER TREATED WITH A MANUAL INJECTION. THE ACT BUTTON WAS UNRESPONSIVE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACKUP PLAN PER A HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633073 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR