BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAL PRDGM INS V2.1 CL EN

    MDR report key: 1812253 · Received August 20, 2010

    Report

    Report Number
    3004209178-2010-82555
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 THAT THE INSULIN PUMP ALARMED MOTOR ERROR SEVERAL TIMES. TROUBLESHOOTING WAS PERFORMED. DURING THE CALL, THE CUSTOMER STATED THAT HE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE ON TWO OCCASIONS. TROUBLESHOOTING WAS PERFORMED. RAN A DISPLACEMENT, MANUAL PRIME AND SELF TESTS AND PASSED. THE CUSTOMER STATED THAT THE ALARM OCCURRED DURING THE BASAL DELIVERY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization