BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972069 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05083
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 25, 2014
    Report Date
    July 3, 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

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS. THE DEVICE PASSED; THE DISPLACEMENT TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, AND EXCESSIVE NO DELIVERY TEST. THE DEVICE WAS RECEIVED WITH A SCRATCHED LCD WINDOW. THE DEVICE WAS RECEIVED WITH CRACKS AT THE CORNER OF THE CASE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, AND A CRACKED BELT CLIP SLOT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP WAS ALARMING BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 124 MG/DL. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE DEVICE TO ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER ALSO REPORTED THAT SHE HAS HAD LOW BLOOD GLUCOSE EVENTS, AS LOW AS 38 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447276 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR