BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1912087 · Received December 1, 2010

    Report

    Report Number
    2954323-2010-01626
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 8, 2010
    Report Date
    January 28, 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)(6)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2010, HE RECEIVED A READING OF 282 MG/DL ON HIS PRECISION XTRA BLOOD GLUCOSE METER AT 9:30 AM AND THEN AT 12:30 PM, HE LOST CONSCIOUSNESS WHILE DRIVING HIS CAR. THE CUSTOMER ALSO REPORTED HE DID NOT RECALL WHAT HAPPENED AT THAT TIME, BUT HE STATED THAT HE WAS AWAKENED BY PARAMEDICS AT THE SCENE OF THE ACCIDENT. ACCORDING TO THE CUSTOMER'S REPORT, AN ADDITIONAL READING OF 17 MG/DL WAS OBTAINED ON AN UNKNOWN COMPETITOR BRAND METER AT THE TIME OF THE EVENT AT 12:30 PM. THE CUSTOMER WAS REPORTEDLY TREATED WITH A GLUCOSE INTRAVENOUS SOLUTION AND THEN TRANSPORTED TO A HEALTH CARE FACILITY WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND KEPT BEING TREATED WITH AN INTRAVENOUS SOLUTION. THE CUSTOMER FURTHER REPORTED THAT AT THE HEALTH CARE FACILITY HE ALSO ATE FOOD AND HAD AN EKG PERFORMED ALONG WITH OTHER UNSPECIFIED "SEVERAL THINGS". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW 44439

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R