BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1811193 · Received August 9, 2010

    Report

    Report Number
    2032227-2010-82206
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST DUE TO AN OUT OF PHASE MOTOR ENCODER SIGNAL. UNABLE TO CONDUCT THE DISPLACEMENT TEST DUE TO THE MOTOR ERROR ALARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MOTOR ERROR ALARM DURING A BOLUS. THE CUSTOMER STATED THAT SHE HAD AN MRI SCAN, BUT SHE DOESN'T KNOW IF THE INSULIN PUMP WAS EXPOSED. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP FAILED 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-522NAS PRDGM INS V2.2 SK EN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR