BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    MDR report key: 1851615 · Received September 28, 2010

    Report

    Report Number
    3004209178-2010-82914
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE OF 68 MG/DL. THE MOTHER STATED THAT THE CUSTOMER BOLUSED 14.0 UNITS FOR DINNER AND TWO HOURS LATER SHE STARTED FEELING SICK. IT WAS STATED THAT THE INSULIN PUMP WAS CHECKED AND FOUND THAT THE DEVICE HAD DELIVERED 22.0 UNITS IN TWO HOURS. THE MOTHER STATED THAT THE PARAMEDICS WERE CALLED AND THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM WHERE SHE WAS TREATED FOR LOW BLOOD GLUCOSE AS HER GLUCOSE LEVEL DROPPED FROM 178 MG/DL TO 157 MG/DL. ADVISED THE MOTHER TO DISCONTINUE USED OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN OF MANUAL INJECTIONS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAB PRDGM INS V2.2 BL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization