BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4122890 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-28765
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 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

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NO ACT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED ON RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE WINDOW THRU RESERVOIR TUBE, CRACKED ON BATTERY TUBE THREADS AND BROKEN PUMP BELT CLIP SLOT. NO MOISTURE DAMAGE INSIDE THE INSULIN PUMP NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE RECEIVED A BUTTON ERROR ALARM DURING BOLUS. CUSTOMER STATES THAT ALARM MAY BE DUE TO MOISTURE. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600795 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR