BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1252829 · Received December 4, 2008

    Report

    Report Number
    3004209178-2008-01017
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 12, 2008
    Report Date
    November 14, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE INSULIN PUMP WAS RETURNED WITH THE DISPLAY SCRATCHED, AND THE RUBBER END CAP STICKER MISSING.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 187 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND FOUND THAT THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE PRIME TEST PASSED. A TUBING CLAMP WAS NOT AVAILABLE AT THE TIME OF THE PHONE CALL TO PERFORM THE HIGH PRESSURE TEST. THE CUSTOMER'S MOTHER STATED THAT THE SCREEN ON THE INSULIN PUMP WAS BADLY SCRATCHED, MAKING IT DIFFICULT TO READ THE SCREEN. NOTHING FURTHER WAS REPORTED.

    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 OPERATIONS MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization