BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841866 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02833
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS SET TO PROPER TIME AND DATE. TIME ADVANCED PROPERLY. THE DEVICE PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION PRIME AND EXCESSIVE NO DELIVERY ALARM TEST. THE UNIT FUNCTIONED PROPERLY. ALL BUTTONS FUNCTIONED PROPERLY, HOWEVER, MOISTURE DAMAGE NOTED ON THE KEYPAD TRACES DURING THE VISUAL INSPECTION. NO BUTTON ERROR ALARM NOTED. UNIT RECEIVED WITH SCRATCHED SCREEN, CRACKED RESERVOIR TUBE LIP AND CRACKED BELT CLIP SLOT.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURN FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD HIGH BLOOD GLUCOSE, THE INSULIN PUMP WAS ALARMING AND HAD A FROZEN DISPLAY. CUSTOMER STATED THAT THE TIME ON THE INSULIN PUMP IS NOT ADVANCING AND THERE IS NO RESPONSE FROM ANY BUTTON. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318991 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR