BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-715NAS PRDGM INS V2.1 SK EN

    MDR report key: 1070361 · Received June 30, 2008

    Report

    Report Number
    3004209178-2008-00466
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BOLUSES AND MONITORED. ALL BOLUSES DELIVERED COMPLETELY THEIR INDICATED AMOUNTS AND WERE PROPERLY RECORDED IN THE BOLUS HISTORY. HOWEVER, THE DEVICE ALARMED NO DELIVERY OUTSIDE OF SPECIFICATION RANGE DURING THE OCCLUSION TEST AS A RESULT OF A FAULTY FORCE SENSOR.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP WAS NOT DELIVERING A BOLUS COMPLETELY. THE BLOOD GLUCOSE READING WAS 109MG/DL. THE CUSTOMER STATED THAT HE CHECKED THE BOLUS HISTORY AND THE DEVICE REGISTERED A PARTIAL BOLUS. THE CUSTOMER ALSO STATED THAT HE DID NOT HAVE ANY ALARMS NOTIFYING HIM THAT THE DEVICE WAS NOT DELIVERING INSULIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1