BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4122876 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-28753
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 26, 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
    ME
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED DISPLACEMENT TEST, OPERATING CURRENTS, SELF TEST AND OFF NO POWER TEST. NO BATTERY OUT LIMIT ALARM NOTED. INSULIN PUMP RECEIVED INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM. INSULIN PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 120 MG/DL. CUSTOMER STATED THAT HE ALSO HAD A BATT OUT LIMIT ALARM AND WAS UNABLE TO CLEAR THE ALARM. CUSTOMER REPORTED THAT HE RECEIVED THE BUTTON ERROR ALARM 2 DAYS AGO. CUSTOMER STATED THAT HE WENT FISHING THE DAY BEFORE. IT WAS EXPLAINED THAT THE BATT OUT LIMIT ALARM OCCURRED BECAUSE THE CUSTOMER TOOK OUT THE BATTERY TO RESET THE PUMP. CUSTOMER WAS ADVISED THAT HIS TIME AND DATE WERE REST AND HIS BASAL RATES HAVE BEEN OFF. CUSTOMER STATED THAT HE WAS LETTING THE PUMP SIT WITHOUT A BATTERY TO FIX THE BUTTON ERROR. PUMP WAS NOT ALARMING AT THE TIME OF THE CALL. IT WAS EXPLAINED THAT THIS WAS NORMAL PUMP BEHAVIOR. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600728 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR