BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142008 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33114
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT A DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 KEYPAD DURING A BOLUS ATTEMPT. THE BLOOD GLUCOSE READING WAS 250 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES WERE OBSERVED. THE CUSTOMER STATED THAT IT WAS VERY HOT THAT DAY, AND NOW NONE OF THE BUTTONS WORKED. A BATTERY REPLACEMENT DID NOT RESOLVE THE ISSUE. SHE ADVISED THAT SHE WOULD TREAT WITH A MANUAL INJECTION AND NOTED THAT SHE HAD HIGH BLOOD GLUCOSE DUE TO EATING WITHOUT A BOLUS. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621433 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 29 YR