BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1811987 · Received August 17, 2010

    Report

    Report Number
    3004209178-2010-82480
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    May 19, 2010
    Report Date
    July 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A CRACK ON THE UPPER LEFT CORNER OF THE CASE NEAR THE LIQUID CRYSTAL DISPLAY WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS IN A CAR ACCIDENT AND THE INSULIN PUMP WAS DAMAGED. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS CRACKED RIGHT ABOVE UPPER LEFT HAND CORNER OF THE DISPLAY AND IT GOES BACK TOWARD THE BATTERY. DAYS LATER, THE HUSBAND REPORTED THAT HIS WIFE WAS HOSPITALIZED FOR LOW BLOOD. THE HUSBAND STATED THAT THE CUSTOMER WAS THE DRIVER AND HER GLUCOSE LEVEL WAS LOW, WHICH MAY HAVE CAUSED THE ACCIDENT. IT WAS ALSO STATED THAT THE CUSTOMER WAS NOT COHERENT. THE PARAMEDICS WERE CALLED, TREATED HER, AND THEN THEY TOOK HER TO THE HOSPITAL. HER BLOOD GLUCOSE LEVEL WAS 180MG/DL. NO FURTHER INFORMATION 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 OPERATIONS MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR