BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972074 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05087
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 27, 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
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM NOTED. THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE DEVICE WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS (ALL CORNERS), CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE LIP, AND CRACKED BELT CLIP SLOT. THE DEVICE WAS RECEIVED WITHOUT BELT CLIP, UNABLE TO VERIFY DAMAGE TO BELT CLIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED BUTTON ERROR WHILE SHE WAS TRYING TO ADMINISTER HERSELF INSULIN BECAUSE SHE KEPT PRESSING THE BUTTONS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 96 MG/DL. CUSTOMER REPORTED STATED SHE WORE THE DEVICE IN HER BRA AS A SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE ALARM. CUSTOMER WAS ADVISED 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
    447155 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR