BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972075 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05075
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 21, 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
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A33 ALARM DURING BASIC OCCLUSION TEST AND UNABLE TO PRIME AT 4.0 LBS DURING PRIME/A33 TEST DUE TO DETACHED END CAP. THE DEVICE HAD SCRATCHED LCD WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED DURING MANUAL PRIME. CUSTOMER DOES NOT KNOW HIS BLOOD GLUCOSE LEVEL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. CUSTOMER STATED THE DEVICE HAS BEEN DROPPED A COUPLE OF TIMES. DRIVE SUPPORT CAP APPEARS TO BE NORMAL. 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
    447278 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR