BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 2001277 · Received February 24, 2011

    Report

    Report Number
    2954323-2011-01732
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 15, 2011
    Report Date
    May 4, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF REPORT ON FOLLOW UP #1 WAS INCORRECTLY POPULATED AS (B)(6) 2011. THE CORRECT DATE IS (B)(6) 2011.

    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.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(4), 2011 SHE RECEIVED A READING OF 230 MG/DL ON HER PRECISION XTRA BLOOD GLUCOSE METER, SELF-ADMINISTERED AN UNKNOWN AMOUNT OF INSULIN AND WAS SUBSEQUENTLY FOUND UNCONSCIOUS BY HER DAUGHTER. PARAMEDICS WERE CALLED AND RECEIVED A READING OF 30 MG/DL ON AN UNKNOWN BRAND OF METER. CUSTOMER WAS TREATED WITH GLUCOSE GEL AT THE SCENE, TRANSPORTED TO A LOCAL HEALTHCARE FACILITY, DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND TREATED WITH ADDITIONAL GLUCOSE VIA AN INTRAVENOUS INFUSION. CUSTOMER ADDITIONALLY REPORTED THAT ON (B)(4) 2011 SHE RECEIVED A READING OF 412 MG/DL ON HER METER WHICH SHE COMPARED TO A READING OF 325 MG/DL ON AN UNKNOWN BRAND OF METER, WITHIN 10 MINUTES. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW 47071

    Patients

    Seq Age Sex Outcome Treatment
    1 Other