BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1864733 · Received October 5, 2010

    Report

    Report Number
    3004209178-2010-83024
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    THE CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP WAS ALARMING. ASSISTED THE CUSTOMER TO CLEAR THE ALARM, BUT THE ALARM KEPT OCCURRING. DURING THE CALL, THE CUSTOMER MENTIONED BEING HOSPITALIZED TWICE FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS OVER 1300 MG/DL, AND THE CUSTOMER WENT INTO A DIABETIC COMA. 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 64 YR Hospitalization