BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 1063167 · Received June 20, 2008

    Report

    Report Number
    3004209178-2008-00433
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 89 MG/DL AT TIME OF CALL. THE CUSTOMER STATED THAT THE DEVICE ALARMED EXCESSIVE NO DELIVERY. TROUBLESHOOTING WAS PERFORMED AND NO DELIVERY ALARM OCCURRED. HOWEVER, THE DEVICE PASSED THE DISPLACEMENT TEST. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAL PRDGM INS V2.2 CL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATONS MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization