BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3250148 · Received July 26, 2013

    Report

    Report Number
    2954323-2013-00402
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    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)(4)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE ACTUAL DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON SOME, UNSPECIFIED, DATE HE RECEIVED A READING OF "300 OR SO" FROM HIS ADC BLOOD GLUCOSE METER. PARAMEDICS WERE CALLED AND UPON ARRIVAL, A READING OF "UNDER 30" WAS RECEIVED ON THEIR UNKNOWN BRAND OF METER. CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTHCARE FACILITY WHERE A READING OF "26" WAS RECEIVED ON THE EMERGENCY ROOM'S UNKNOWN BRAND OF METER. IT IS UNKNOWN HOW MUCH TIME MAY HAVE ELAPSED BETWEEN THE VARIOUS READINGS. IT IS ALSO UNKNOWN WHAT TREATMENT MAY HAVE BEEN RENDERED BY THE PARAMEDICS OR THE HOSPITAL. HOWEVER, CUSTOMER NOTED HE RECEIVED STAPLES IN HIS HEAD, LOST HIS JOB, REQUIRES THE USE OF AN ELECTRIC WHEELCHAIR AND IS NOW DISABLED. CUSTOMER ALSO NOTED HE HAD BEEN BROUGHT TO THE EMERGENCY ROOM ON TWO OCCASIONS, BUT THE DETAILS OF THE OTHER EMERGENCY ROOM VISIT ARE UNKNOWN. NO ADDITIONAL INFORMATION REGARDING THESE EVENTS WAS PROVIDED BY THE CUSTOMER BECAUSE HE REFUSED TO PROVIDE THEM. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350619 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1357921

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| S