BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4133229 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31464
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM WAS NOTED DURING TESTING. THE INSULIN PUMP HAD A CRACKED CASE AT A DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND A CRACKED 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 REPORTED THAT THE INSULIN PUMP RECEIVED A BUTTON ERROR ALARM. BLOOD GLUCOSE VALUE IS 53 MG/DL; TREATED WITH GRAPES. CUSTOMER STATED HE THINKS HIS BLOOD GLUCOSE IS LOW BECAUSE OF HIS ACTIVITY. CUSTOMER STATED THAT THE DEVICE WAS EXPOSED TO SWEAT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611007 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS A000257056

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR