BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3092978 · Received May 3, 2013

    Report

    Report Number
    2954323-2013-00252
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 11, 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 (1261553) 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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A CALLER, CALLING ON BEHALF OF A CUSTOMER REPORTED THAT THE CUSTOMER RECEIVED AN UNSPECIFIED ERROR MESSAGE ON THE DISPLAY OF HER ADC BLOOD GLUCOSE METER, NOTING IT WAS AN INTERMITTENT PROBLEM. CALLER FURTHER REPORTED THAT ON (B)(6), 2013, (APPROXIMATELY ONE WEEK AFTER FIRST NOTICING THE ERROR MESSAGE), CUSTOMER BEGAN TO EXPERIENCE "DIZZINESS AND VOMITING", AND SUBSEQUENTLY A LOSS OF CONSCIOUSNESS WHICH RESULTED IN "BRUISES AND BLURRING ON THE RIGHT SIDE OF HER EYES". NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER SELF-TREATED BY APPLYING AN ICE PACK TO THE AREA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195481 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1261553

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other