BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4871426 · Received June 26, 2015

    Report

    Report Number
    2032227-2015-20370
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    THE INSULIN PUMP WAS RECEIVED WITH CORRODED KEYPAD TRACES. HOWEVER, ALL OF THE BUTTONS ARE FUNCTIONING PROPERLY AND NO BUTTON ERROR ALARM DURING OUR TESTING. THE INSULIN PUMP HAS CRACKED BATTERY TUBE THREAD, CRACKED BELT CLIP SLOT, CRACKED RESERVOIR TUBE LIP, CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, CRACKED ON DISPLAY WINDOW AND STAINED END CAP STICKER NOTED.

    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 165 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE RECALLED. 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
    414020 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR