BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAB PRDGM INS V2.1 BL EN

    MDR report key: 1103218 · Received August 8, 2008

    Report

    Report Number
    2032227-2008-01363
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 28, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    THE CUSTOMER STATED THAT HE WAS HOSPITALIZED TWICE DUE TO DIABETIC KETOACIDOSIS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME, DISPLACEMENT AND SELF TESTS. THE CUSTOMER DID NOT HAVE A TUBING CLAMP AT THE TIME OF THE PHONE CALL IN ORDER TO PERFORM THE HIGH PRESSURE TEST. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD ALARMED MOTOR ERROR ON TWO SEPARATE OCCASIONS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A PLAN OF MANUAL INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715LNAB PRDGM INS V2.1 BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization