BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2090173 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81381
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 GIVING HERSELF 300 UNITS OF INSULIN. ADVISED THE CUSTOMER TO TREAT HER BLOOD GLUCOSE RIGHT AWAY. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS 42MG/DL BEFORE CALLING THE HELPLINE. CUSTOMER BEGAN TO TREAT HER GLUCOSE WITH ORANGE JUICE AND HARD CANDY. THE CUSTOMER STATED THAT THE RESERVOIR WAS REMOVED FROM THE INSULIN PUMP AND THE RESERVOIR WAS EMPTY. THE CUSTOMER HAD DISCONNECTED DURING HER INFUSION SET CHANGE EARLIER IN THE DAY. INSTRUCTED CUSTOMER TO MEASURE AGAIN HER GLUCOSE AND IT WAS 59MG/DL. THE CUSTOMER STATED THAT SHE WILL CALL HER FRIEND WHO IS A NURSE TO TAKE HER TO THE HOSPITAL. THE CUSTOMER CALLED BACK AND STATED THAT SHE DID NOT REWIND THE INSULIN PUMP PRIOR TO INSERTING THE RESERVOIR INTO THE INSULIN PUMP AND FORCED THE RESERVOIR INTO THE INSULIN PUMP WHILE STILL CONNECTED AND PUSHED ALL 300 UNITS INTO HER BODY. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE IS STABLE. 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-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization