BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933295 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-87039
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BUTTON ERROR ALARM AND NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. UNABLE TO PERFORM DISPLACEMENT, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST, DUE TO NO BUTTON RESPONSE. NO FLASHING SCREEN ANOMALY NOTED. INSULIN PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, BROKEN RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER ALSO REPORTED LOW BLOOD GLUCOSE LEVELS, WHICH SHE TREATED BY EATING SUGAR. THE BLOOD GLUCOSE READING WAS 62 MG/DL. SHE STATED THAT HER BLOOD GLUCOSE WAS LOW DUE TO EXERCISING AND PLAYING TENNIS. THE CUSTOMER REPORTED THAT SHE BOLUSED AND THEN THE DEVICE STARTED FLASHING. SHE REPLACED THE BATTERY AND THE INSULIN PUMP STARTED ALARMING BUTTON ERROR. ADVISED DISCONTINUATION OF THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409384 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 66 YR