BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945043 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-87795
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO UNEXPECTED NUMBERS RAMPING NOTED. THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. THE INSULIN PUMP RECEIVED HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD AN UNRESPONSIVE BUTTON. THE BLOOD GLUCOSE READING WAS 308 MG/DL. THE CUSTOMER STATED THAT THE DEVICE WAS NOT WORKING AT FIRST AND IT WENT THROUGH A SERIES OF NUMBERS. HE THEN DISCONNECTED IT FROM HIMSELF AND TOOK THE BATTERY OUT, WHICH IS WHEN THE ACT BUTTON STOPPED RESPONDING. HE ALSO NOTED THAT HE FEELS AS THOUGH HE HAS HIGH BLOOD GLUCOSE LEVELS BUT KNOWS HOW TO DEAL WITH IT AND WOULD CALL HIS DOCTOR. THE CUSTOMER STATED THAT HE WAS RIDING HIS BIKE AND DOES SWEAT, BUT THIS IS NORMAL FOR HIM. ADVISED DISCONTINUATION AND REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421477 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR