BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1152826 · Received September 4, 2008

    Report

    Report Number
    2954323-2008-02489
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 6, 2008
    Report Date
    September 4, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED METER . THE HIGH READING COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN RANGE SPEC, THE STANDARD DEVIATION WAS WITHIN SPEC AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. NOTE: THE CUSTOMER DID NOT REPORTEDLY WASH HANDS PRIOR TO TESTING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE FIRST DAY IN THEIR INSULIN DOSE WAS INCREASED BY A NURSE FROM 20 TO 22 UNITS, THE CUSTOMER REPORTEDLY EXPERIENCED A HYPOGLYCEMIC EVENT AND LOSS OF CONSCIOUSNESS. THE PARAMEDICS WERE CALLED AND THE CUSTOMER WAS REPORTEDLY TREATED WITH GLUCOSE TABLETS AND "HYPO STOP". THERE WAS NO REPORT OF MEDICAL DIAGNOSIS FOR SEVERE HYPOGLYCEMIA. THE CUSTOMER REPORTED THE PARAMEDICS TOLD THEM THEIR INSULIN DOSE WAS TOO HIGH. ADDITIONALLY, THE CUSTOMER REPORTED OBTAINING A READING OF 5.5 MMOL/L ON THEIR METER AND COMPARING TO A READING OF 3.7 MMOL/L OBTAINED ON THE PARAMEDIC'S METER. IT IS UNCLEAR IF THE ADC METER READING WAS TAKEN BEFORE OR AFTER THE REPORTED EVENT OR IF THE CUSTOMER ADJUSTED THEIR MEDICATION BASED ON THE ADC METER READING. 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 PRECISION XTRA/OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. NI 80371

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention