BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3092947 · Received May 3, 2013

    Report

    Report Number
    2032227-2013-01640
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED FUNCTIONAL TESTING. HOWEVER, THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR. UNABLE TO COMPLETE ALL FUNCTIONAL TESTING DUE TO THE PRIME ANOMALY. THE INSULIN PUMP HAD A CRACKED CASE ON THE LCD DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE LIP AND A SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVELS CLOSE TO 300 MG/DL. THE CUSTOMER FELT THAT THE INSULIN PUMP CAUSED THE EVENT, AND REQUESTED A REPLACEMENT. THE CUSTOMER EXPERIENCED NAUSEA, VOMITING, EXCESSIVE THIRST AND URINATION. THE CUSTOMER ALSO STATED THAT HE HAD AN INFECTION. THE CUSTOMER STATED HE WAS BOLUSING, BUT HIS BLOOD GLUCOSE LEVELS KEPT ELEVATING. THE CUSTOMER CHANGED THE INFUSION SET, BUT THAT DID NOT HELP. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED PER HIS REQUEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194763 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization