BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 2221062 · Received August 23, 2011

    Report

    Report Number
    2954323-2011-04285
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 1, 2011
    Report Date
    October 19, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS 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 EXPERIENCING CHEST PAINS, SHORTNESS OF BREATH, AND "WEIRD FEELINGS" AND SELF PRESENTED TO A HEALTH CARE FACILITY. CUSTOMER REPORTED RECEIVING A READING OF 220 MG/DL ON HIS ADC METER WHICH WAS HIGHER THAN A READING OF 140 MG/DL RECEIVED ON HIS HEALTH CARE PROFESSIONAL'S (HCP) METER. CUSTOMER ADDITIONALLY REPORTED A COMPARISON OF 270 MG/DL (OBTAINED ON AN UNKNOWN METER) WHICH WAS HIGHER THAN A READING OF 200 MG/DL (HCP METER). NO DIAGNOSIS WAS PROVIDED. CUSTOMER WAS GIVEN A "SHOT" WITH UNSPECIFIED MEDICATION WHICH WAS A CHANGE TO THE CUSTOMER'S NORMAL MEDICATIONS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW 48182

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention