BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS

    MDR report key: 1973853 · Received January 18, 2011

    Report

    Report Number
    3004209178-2011-80166
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIS BLOOD GLUCOSE READING WAS 515MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE WAS EXPERIENCING HIGH BLOOD GLUCOSE FOR SEVERAL HOURS. THE CUSTOMER CHANGED THE INFUSION SET THE DAY BEFORE. THE CUSTOMER BOLUSED FOR DINNER, WENT TO BED, AND WOKE UP VOMITING. THE CUSTOMER STATED THAT HE HAS CHANGED THE SITE TWICE AND HE WAS NOT RECEIVING ANY INSULIN. THE CUSTOMER STATED THAT HE HAS GIVEN OVER FORTY UNITS OF INSULIN AND HIS BLOOD GLUCOSE DID NOT DROP. ADVISED THE CUSTOMER TO REVERT TO BACK UP PLAN UNTIL THE REPLACEMENT OF THE DEVICE ARRIVES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization