BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4211634 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44909
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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.

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED BUTTON ERROR ALARM WAS NOTED. NO UNEXPECTED FAILED BATTERY TEST ALARM WAS NOTED. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST AND THE OFF NO POWER TEST. THE OPERATING CURRENTS WERE WITHIN SPECIFICATION. THE INSULIN PUMP HAD INTERMITTENT ACT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS, A CRACKED BELT CLIP SLOT AND A STAINED END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP DURING A BOLUS. CUSTOMER ALSO RECEIVED A FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 211 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692480 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR