BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1853176 · Received October 5, 2010

    Report

    Report Number
    2954323-2010-01373
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 4, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE DOES NOT INVOLVE A PRODUCT MALFUNCTION AND NO PRODUCT INVESTIGATION IS NECESSARY. ADC CUSTOMER SERVICE PROVIDED TRAINING TO THE CUSTOMER ON HOW TO USE HER BLOOD GLUCOSE METER. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CALLED ADC CUSTOMER SERVICE AND ASKED TO BE TRAINED ON HOW TO USE HER FREESTYLE LITE BLOOD GLUCOSE METER. ADC CUSTOMER SERVICE PROVIDED THE REQUESTED TRAINING AND WHILE THE CUSTOMER WAS ANSWERING THE TROUBLESHOOTING SURVEY QUESTIONS, SHE REPORTED THAT APPROXIMATELY A WEEK AND A HALF PRIOR (THE CUSTOMER DID NOT HAVE THE EXACT DATE AND TIME OF THE EVENT) SHE COULD NOT "REGULATE" HER BLOOD SUGAR AS SHE WAS NOT FAMILIAR WITH HER METER AND NOT ABLE TO OBTAIN READINGS. THE CUSTOMER FURTHER REPORTED SHE EXPERIENCED DISORIENTATION, HEADACHES, WEAKNESS, FATIGUE AND "BLACK OUTS". SHE REPORTEDLY LOST CONSCIOUSNESS, BUT NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED AND NO MEDICATIONS WERE TAKEN TO COUNTERACT THE EVENT. THE CUSTOMER ALSO REPORTED SHE ATE FOOD TO AMELIORATE HER SYMPTOMS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1005118

    Patients

    Seq Age Sex Outcome Treatment
    1 Other