BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2231045 · Received July 19, 2011

    Report

    Report Number
    2032227-2011-01791
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 9, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS DROPPED TO 190 MG/DL AFTER A MANUAL INJECTION, BUT WENT BACK UP TO 417 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE PRIME TEST. IT WAS ALSO STATED THAT THE INSULIN PUMP WOULD NOT REWIND AFTER GETTING A BATTERY OUT LIMIT ALARM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR