BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2243738 · Received July 29, 2011

    Report

    Report Number
    3004209178-2011-82381
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    April 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP DOES NOT ALWAYS ALARM WHEN THE RESERVOIR IS EMPTY. THE CUSTOMER STATED THAT THE ANOMALY HAS HAPPENED FOR SEVERAL MONTHS. TROUBLESHOOTING WAS PERFORMED. RAN A FIXED PRIME AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST TWICE AND THE INSULIN PUMP DID NOT ALARM. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR