BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1812261 · Received August 20, 2010

    Report

    Report Number
    3004209178-2010-82565
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE BUTTONS AND A BUTTON ERROR ALARM AS A RESULT OF CORRODED KEYPAD TRACES. FURTHER TESTING WAS NOT PERFORMED DUE TO THE UNRESPONSIVE BUTTONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE, AND THE INSULIN PUMP ALARMED BUTTON ERROR. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE HAD A LOW BLOOD GLUCOSE REACTION OF 22MG/DL. THE CUSTOMER COLLAPSED AND HIS WIFE FOUND HIM. THE CUSTOMER WAS TAKEN TO THE HOSPITAL. THE CUSTOMER'S BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 241MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization