BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2010715 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-80298
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE THREE DAYS AGO. THE CUSTOMER STATED THAT HE WAS CONNECTED, BUT HE WAS NOT ABLE TO SEE THE SCREEN ON THE DEVICE. THE CUSTOMER STATED THAT HE PRESSED THE BUTTONS AND THE BACK LIGHT DID NOT TURN ON. TROUBLESHOOTING WAS PERFORMED. THE ALARM HISTORY REVEALED OFF NO POWER AND MOTOR ERROR ALARM. THE CUSTOMER STATED THAT THE NURSE TOOK THE BATTERY OUT AND REPLACED. THE INSULIN PUMP WAS ABLE TO REWIND AND PRIME; AND THE LIGHT CAME BACK ON. NO FURTHER INFORMATION 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-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization