BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2911127 · Received January 11, 2013

    Report

    Report Number
    2954323-2013-00010
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    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 (1171694) 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. NOTE: THE METER'S MANUFACTURE DATE IS UNKNOWN, THE DATE ENTERED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THIS MEDICAL EVENT.

    Description of Event or Problem · 1

    CALLER (CUSTOMER'S WIFE) REPORTED THAT PRIOR TO GOING TO THE HOSPITAL FOR A SCHEDULED SURGERY A CUSTOMER OBTAINED A READING OF 200 MG/DL ON HIS ADC METER WHICH WAS LOWER THAN A READING OF 300 MG/DL OBTAINED AT THE HOSPITAL ON UNKNOWN BRAND HCP METER. IT WAS FURTHER REPORTED THAT "WHILE WAITING AT THE HOSPITAL" A READING OF 180 MG/DL WAS OBTAINED ON CUSTOMER'S ADC METER. NO SELF-TREATMENT WAS REPORTED. MEDICAL SURVEY WAS NOT COMPLETED BECAUSE CALLER DECLINED TO CONTINUE TROUBLESHOOTING. PRIOR TO DISCONNECTING THE PHONE CALL CALLER STATED THAT CUSTOMER SUSTAINED AN UNSPECIFIED INJURY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18427 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1171694

    Patients

    Seq Age Sex Outcome Treatment
    1 Other