BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715RNAB PRDGM INS BL EN ML PR

    MDR report key: 1231873 · Received November 12, 2008

    Report

    Report Number
    2032227-2008-01937
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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 STATED THAT THE SCREEN ON THE INSULIN PUMP WAS BLANK. TROUBLESHOOTING WAS PERFORMED, BUT THE DISPLAY COULD NOT BE RESTORED. THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READING WAS 372 MG/DL. THE CUSTOMER WAS ADVISED TO REVERT TO A BACKUP PLAN TO TREAT HER DIABETES. HOWEVER, THE CUSTOMER CALLED BACK AND REPORTED THAT SHE HAD NOT TAKEN ANY INSULIN TO TREAT HER BLOOD GLUCOSE. THE CUSTOMER ALSO REPORTED EXPERIENCING CHEST PAIN. PARAMEDICS WERE CALLED AND ARRIVED TO ASSIST THE CUSTOMER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715RNAB PRDGM INS BL EN ML PR INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention