BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAP PRDGM INS V2.2 PL EN

    MDR report key: 1882614 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-83163
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST AND ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST AS A RESULT OF A FAULTY FORCE SENSOR. FURTHER TESTING WAS NOT PERFORMED DUE TO THE PRIME ANOMALY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 540MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR ONCE. THE CUSTOMER STATED THAT SHE NOTICED THE MOTOR DOES NOT ALWAYS STOP OR SLOW DOWN WHEN SHE RUNS A MANUAL PRIME, AND THE INSULIN WAS SQUIRTING OUT. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization