BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3083518 · Received April 29, 2013

    Report

    Report Number
    2032227-2013-01558
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    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 GAVE A MOTOR ERROR ALARM DURING THE BASIC OCCLUSION TEST, AND GAVE OTHER ALARMS DURING THE PRIME TEST DUE TO A LOOSE/PROTRUTED DRIVE SUPPORT DISK. THE MOTOR PASSED THE MOTOR TEST. THE INSULIN PUMP ALSO HAD A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MOTOR ERROR ALARM AND INSULIN SQUIRTING OUT DURING THE MANUAL PRIME. THE CUSTOMER STATED THAT THE INSULIN PUMP WILL NOT EXIT THE PRIME SCREEN. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. THE REPORTED BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 101 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185839 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR