BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4962236 · Received August 3, 2015

    Report

    Report Number
    2032227-2015-24807
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/DELIVERY TEST AND EXCESSIVE NO DELIVERY TEST. NO EXCESSIVE NO DELIVERY ALARMS NOTED DURING TESTING. ALL BUTTONS FUNCTIONING PROPERLY. HOWEVER, FOUND CORRODED KEYPAD TRACES. UNIT RECEIVED WITH BROKEN RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED DISPLAY WINDOW, MISSING END CAP STICKER AND CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S KEYPAD WAS UNRESPONSIVE. THE CUSTOMER ALSO REPORTED THAT THE DEVICE RECENTLY HAD A NO DELIVERY ALARM. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 440 MG/DL, WHICH WAS TREATED WITH A MANUAL INJECTION. THE CUSTOMER REPORTED THAT THE DEVICE WAS WET TO THE TOUCH. CUSTOMER ALSO REPORTED THAT HER BLOOD GLUCOSE LEVEL RECENTLY DROPPED FROM 145 MG/DL TO 59 MG/DL. TROUBLESHOOTING COULD NOT BE PERFORMED AS THE KEYPAD WAS UNRESPONSIVE. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504696 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention