BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933518 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03820
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO BUTTON RESPONSE DUE TO MOISTURE DAMAGE TO KEYPAD TRACE. MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY. MINOR SCRATCHES ON LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO KEYPAD ANOMALY.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A KEYPAD ISSUE WITH THE INSULIN PUMP. CUSTOMER STATES THAT THE ESCAPE BUTTON IS NOT RESPONSIVE. CUSTOMER STATES THAT THE INSULIN PUMP GOT WET, BUT NOT SUBMERGED. THE BLOOD GLUCOSE READING WAS 280 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411046 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR