BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1993956 · Received February 16, 2011

    Report

    Report Number
    2954323-2011-01649
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    December 12, 2010
    Report Date
    June 2, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(4)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READING THE CUSTOMER REPORTED WAS NOT FOUND IN METER MEMORY.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6), 2010 HE RECEIVED A READING OF 150 MG/DL ON HIS PRECISION XTRA BLOOD GLUCOSE METER. IT WAS FURTHER REPORTED CUSTOMER EXPERIENCED DIAPHORESIS, WAS INCOHERENT, "COULD NOT SEE", "STARTED TO JERK" AND "WAS UNABLE TO UNDERSTAND WHAT WAS GOING ON". PARAMEDICS WERE CALLED AND RECEIVED A READING OF 37 MG/DL ON AN UNKNOWN BRAND OF METER. THE RESULTS WERE REPORTEDLY OBTAINED AT THE SAME TIME. CUSTOMER WAS TREATED AT THE SCENE WITH GLUCOSE VIA AN INTRAVENOUS INFUSION. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW 45840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention