BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4212137 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44838
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 28, 2014
    Report Date
    September 30, 2014
    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 WITHIN OPERATING CURRENTS WITHIN SPECIFICATIONS DURING TESTING . THE INSULIN PUMP PASSED SELF TEST, EXCESSIVE NO DELIVERY ALARM, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND DISPLACEMENT TESTS. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON LIQUID CRYSTAL DISPLAY WINDOW AND RESERVOIR TUBE WINDOW AND CRACKED CASE AT DISPLAY WINDOW CORNERS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THERE ARE CRACKS ON THE INSULIN PUMP. THE BLOOD GLUCOSE READING IS 123 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693543 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR