BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 3102957 · Received May 9, 2013

    Report

    Report Number
    2954323-2013-00262
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 21, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE ACTUAL DATE OF THE REPORTED MEDICAL EVENT IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (4500161090) 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 A CALIBRATION ISSUE WITH HIS METER THAT PREVENTED HIM OBTAINING A BLOOD GLUCOSE RESULT. CUSTOMER STATED HE OPENED A NEW BOX OF TEST STRIPS, APPLIED A BLOOD SAMPLE, AND COULD NOT GET A RESULT DUE TO 'LOT -----' APPEARING ON THE DISPLAY OF HIS ADC BLOOD GLUCOSE METER. CUSTOMER ADDITIONALLY REPORTED EXPERIENCING SYMPTOMS DESCRIBED AS "LETHARGY" AND "A LITTLE CONFUSION". CUSTOMER SELF-TREATED WITH FOOD AND INSULIN AND SELF-PRESENTED TO A HEALTH CARE PROFESSIONAL WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH GLUCOSE IN THE FORM OF ORAL, GEL, AND INJECTION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203926 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 4500161090

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention