BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522LNAS PRDGM INS SK EN ML

    MDR report key: 1931486 · Received December 10, 2010

    Report

    Report Number
    2032227-2010-83395
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING PRIMING AND DISPLACEMENT TEST DUE TO A CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM THE EXCESSIVE NO DELIVERY ALARM TEST DUE TO THE MOTOR DAMAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A NO DELIVERY ALARM WHILE ATTEMPTING TO PRIME. THE INSULIN PUMP ALSO ALARMED MOTOR ERROR DURING THE CALL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP DID NOT PASS THE DISPLACEMENT TEST. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAS PRDGM INS SK EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR