BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1812061 · Received August 18, 2010

    Report

    Report Number
    3004209178-2010-82525
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE, AND THE INSULIN PUMP ALARMED NO DELIVERY DURING A NORMAL BASAL DELIVERY, THEN WHEN HE TRIED TO REWIND THE DEVICE AND DO A MANUAL PRIME, THE DEVICE ALARMED NO DELIVERY AGAIN. TROUBLESHOOTING WAS PERFORMED. RAN A FIXED PRIME TEST AND PASSED. THE CUSTOMER STATED THAT HE RECEIVED SEVERAL NO DELIVERY ALARMS IN THE PAST WEEK. ADVISED CUSTOMER TO CONTACT A HEALTH CARE PROFESSIONAL OR TO VISIT THE EMERGENCY ROOM. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization