BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4901928 · Received July 9, 2015

    Report

    Report Number
    3004209178-2015-72575
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGED ON THE KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED DURING OUR TESTING. THE INSULIN PUMP HAS CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHED LCD WINDOW, CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT AT BATTERY TUBE THREADS AREA, BROKEN RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE WINDOW.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE, SHE WAS CHECKING HOW MUCH INSULIN WAS LEFT IN THE RESERVOIR AND IT ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 188 MG/DL. TROUBLESHOOTING FOR BUTTON ERROR WAS PERFORMED. CUSTOMER DIDN'T RECALL ANY SIGNIFICANT EVENT WHICH MAY HAVE CAUSE THE DEVICE TO ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, REVERT TO BACK UP PLAN, AND THE DEVICE NEED TO BE REPLACED. SHE AGREED TO RETURN THE DEVICE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447561 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 27 YR