BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2033941 · Received March 18, 2011

    Report

    Report Number
    3004209178-2011-80724
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPOGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 36 MG/DL. THE CUSTOMER STATED THAT PRIOR TO THE EVENT, SHE WAS ON HER WAY HOME AND BACKED INTO A GUARD RAIL WHERE HER CAR WENT UP 3 FEET AND HAD TO BE RESCUED BY PARAMEDICS. THE CUSTOMER ALSO STATED THAT SHE USES A QUICK-SET INFUSION SET AND CHANGED HER INFUSION SET 3 DAYS BEFORE THE EVENT. THE CUSTOMER THEN STATED THAT SHE HAD LATER RECEIVED A MOTOR ERROR 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 PUERTO RICO OPERATIONS MED-REL MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization UNOMEDICAL INSULIN INFUSION SET - MMT-386