BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    MDR report key: 1932899 · Received December 14, 2010

    Report

    Report Number
    2032227-2010-83443
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER REC'D AN UNWANTED BOLUS OF 5 UNITS DURING THE NIGHT WHILE HE WAS SLEEPING. THE WIFE ALSO STATED THAT THE CUSTOMER REC'D ANOTHER UNWANTED BOLUS DAYS BEFORE, AND THE PARAMEDICS WERE CALLED FOR ASSISTANCE. THE CUSTOMER BLOOD GLUCOSE READING WAS 451MG/DL. IT WAS STATED THAT THE DEVICE GAVE 7 UNITS, WHICH THE CUSTOMER DID NOT WANT. IT WAS STATED THAT THE WIFE CALLED THE AMBULANCE TO GET HELP IN TREATING THE CUSTOMER'S LOW BLOOD GLUCOSE. PROGRAMMING WAS COMPLETE, NO ALARMS, AND NO DAMAGE TO CASE OR SCREEN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAS PRDGM INS SK EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization