BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1032825 · Received April 21, 2008

    Report

    Report Number
    3004209178-2008-00262
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    April 6, 2008
    Report Date
    April 7, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE AND THE READING WAS 23 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP ALSO PASSED THE DISPLACEMENT TEST. PRIOR TO THE HOSPITALIZATION THE CUSTOMER STATED THAT SHE GAVE A BOLUS FOR A LATE BREAKFAST. SHORTLY BEFORE AN EARLY SUPPER SHE LOST CONSCIOUSNESS AND WAS TAKEN TO THE HOSPITAL. FOUND DURING THE PHONE CALL THAT THE CUSTOMER WAS VERY NEW TO INSULIN PUMP THERAPY AND MAY NEED FURTHER TRAINING. ON ANOTHER PHONE CALL IT WAS STATED THE INSULIN PUMP WAS ALARMING AND ALL OF THE BUTTONS WERE FROZEN AND HAD NOT RESPONSE. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED DUE TO THE BUTTON ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization