BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAB PRDGM INS BL EN ML

    MDR report key: 1780322 · Received July 26, 2010

    Report

    Report Number
    2032227-2010-81994
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 3, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 SHE WENT TO THE HOSPITAL FOR LOW BLOOD GLUCOSE. THE CUSTOMER ALSO REPORTED THAT SHE WAS IN A CAR ACCIDENT AND FRACTURED HER ARM. THE CUSTOMER WAS NOT ABLE TO TROUBLESHOOT THE DEVICE BECAUSE HE HAD ONLY ONE WORKING ARM AND THE NURSE WAS NO WILLING TO ASSIST HER. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAB PRDGM INS BL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization