BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1882617 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-83170
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 582MG/DL. THE CUSTOMER STATED THAT SHE DID NOT FEEL GOOD AND TREATED HER GLUCOSE LEVEL, BUT IT CONTINUED RISING. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE FAINTED, AND SHE WAS SHOWING SIGNS OF DIABETES KETOACIDOSIS. THE CUSTOMER ALSO STATED THAT SHE CHANGES THE INFUSION SETS EVERY THREE DAYS. THE PROGRAMMING, BASAL, TIME, DATE, DAILY TOTALS, AND BOLUS HISTORY WERE CORRECT. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. NO FURTHER INFO 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 41 YR Hospitalization