BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1850165 · Received September 22, 2010

    Report

    Report Number
    3004209178-2010-82891
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD A BLANK DISPLAY AS A RESULT OF A CORRODED BATTERY TUBE AND BATTERY CAP. FURTHER TESTING WAS NOT PERFORMED DUE TO THE BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP SHUT OFF INADVERTENTLY. THE CUSTOMER STATED THAT HE TRIED TO BOLUS, BUT THE DEVICE DID GO FURTHER THAN 0.5 UNITS AND STARTED OVER AGAIN. THE CUSTOMER ALSO STATED THAT THE NUMBERS ON THE DEVICE DISAPPEARED. TROUBLESHOOTING WAS PERFORMED. THE BOLUS HISTORY REVEALED THAT A DELIVERY OF 1.5 UNITS WAS ENTERED AND IT STOPPED AT 0.8 UNITS. THE ALARM HISTORY REVEALED SEVERAL LOW RESERVOIR ALARMS. RAN A 1.0 UNIT TEST AND THE INSULIN EXITED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAS PRDGM INS V2.2 SK EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR