BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4232998 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48606
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE AT ELECTRONIC ASSEMBLY. UNIT RECEIVED MOISTURE DAMAGED AT MOTOR ASSEMBLY. PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW. UNIT RECEIVED WITH CRACKED BATTERY TUBE THREADS. PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD VISIBLE MOISTURE UNDER THE DISPLAY SCREEN AFTER BEING EXPOSED TO STEAM FROM THE SHOWER. BLOOD GLUCOSE LEVEL WAS 252 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715283 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR