BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2781317 · Received October 10, 2012

    Report

    Report Number
    2954323-2012-06625
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 14, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4) 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 (1176377) 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'S HUSBAND REPORTED CUSTOMER RECEIVED THE FOLLOWING READINGS FROM HER ADC BLOOD GLUCOSE METER, WHICH WERE LOWER THAN SHE FELT: 80 MG/DL ON (B)(6) 2012 AT 10 AM, 50MG/DL "BY (B)(6)" (CALLER CANNOT RECALL ACTUAL DATE/TIME) AND 55 MG/DL "BY (B)(6)" (CALLER CANNOT RECALL THE DATE/TIME). CALLER FURTHER REPORTED THAT ON (B)(6) 2012 IN THE MORNING, WHILE HAVING BREAKFAST, CUSTOMER WAS "DISORIENTED, DIZZY" AND FELT "VERY BAD". HE ALSO NOTED THE CUSTOMER FELT "UNEASY" THE NIGHT BEFORE. PARAMEDICS WERE CALLED AND CUSTOMER WAS "RUSHED TO THE HOSPITAL DUE TO DIABETIC SYMPTOMS". IT WAS FURTHER REPORTED THAT AT THE HOSPITAL, "UPON CHECKING SHE HAS HAD A HIGH BLOOD SUGAR LEVEL AND SO WAS CONFINED THERE FOR A FEW DAYS". NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THE INITIAL CALL EXCEPT THAT THE CUSTOMER BELIEVED SHE HAD SUSTAINED AN UNSPECIFIED "INJURY" AS A RESULT OF THIS ISSUE. MULTIPLE, UNSUCCESSFUL, ATTEMPTS TO CONTACT THIS CUSTOMER TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1176377

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O