BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4862349 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19849
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. THE INSULIN PUMP PASSED REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND BROKEN BATTERY TUBE THREADS.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED WITH A BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 270 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE RECALLED. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE, STATING HE MISCALCULATED CARBOHYDRATES UNITS, WHICH HE BELIEVED CAUSED HIGH BLOOD GLUCOSE. IT WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. IT WAS FURTHER ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED UPON THAT THE PRODUCT WOULD BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405711 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR