BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAS PRDGM INS SK EN US LN

    MDR report key: 1020657 · Received March 27, 2008

    Report

    Report Number
    2032227-2008-00561
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 INITIALLY STATED THAT THE BUTTONS WERE NOT RESPONDING AS THEY SHOULD. THE CUSTOMER THEN STATED THAT HE WAS TREATED IN THE EMERGENCY ROOM FOR LOW BLOOD GLUCOSE AND THE READING WAS 15 MG/DL. THE CUSTOMER ALSO STATED THAT THERE WAS A DISCREPANCY BETWEEN THE RESERVOIR VOLUME AND THE ACTUAL AMOUNT OF INSULIN LEFT IN THE RESERVOIR. THE CUSTOMER STATED THAT THERE WERE 20 UNITS OF INSULIN THAT WERE UNACCOUNTED FOR. ADVISED THE CUSTOMER THAT THE INSULIN PUMP SHOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512LNAS PRDGM INS SK EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention