BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972061 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05088
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE AND BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. THE DEVICE HAD CRACKED DISPLAY WINDOW CORNER, SCRATCHED LCD WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT AT BATTERY TUBE THREADS AREA, AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER'S INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 405 MG/DL. CUSTOMER'S MOTHER REPORTED THAT HT CUSTOMER WAS SWEATING AS A SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE DEVICE TO ALARM. CUSTOMER'S MOTHER WAS ADVISED THE CUSTOMER HAS TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448487 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR