BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    MDR report key: 1951853 · Received December 28, 2010

    Report

    Report Number
    2032227-2010-83589
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT SHE FELT HER SITE WAS CAUSING THE ISSUE AND SHE CHANGES THE LOCATION. THE CUSTOMER STATED THAT WHILE SHE WAS GIVING HERSELF A MANUAL INJECTION OF 5.0UNITS, THE CUSTOMER NOTICED THAT TIME WAS INCORRECT AND CHANGED. THE CUSTOMERS' SPEECH BECAME SLOWED AND SLURRED. THE CUSTOMER SOUNDS VERY EXHAUSTED AND CONFUSED. THE CUSTOMER RECHECKED HER GLUCOSE LEVEL AND IT WAS 450MG/DL. THE PARAMEDICS WERE CALLED AND CAME TO THE CUSTOMER'S HOUSE. SPOKE TO THE PARAMEDICS TO INFORM THEM THE SITUATION. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization