BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1934779 · Received December 21, 2010

    Report

    Report Number
    2954323-2010-01707
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 24, 2010
    Report Date
    July 13, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DATE OF THE MEDICAL EVENT IS UNKNOWN. IN ADDITION, THE READINGS OF 74MG/DL AND 161MG/DL WHEN PLOTTED ON THE PARKES ERROR GRID FELL WITHIN THE "B" ZONE SHOWING THE DIFFERENCE IN VALUES IS NOT CONSIDERED CLINICALLY SIGNIFICANT. CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED BACK FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER ON FOLLOW-UP #1 SHOULD HAVE REFLECTED THE DATE OF (B)(6) 2011. AS PER THE ARRANGEMENTS DISCUSSED WITH (B)(4) AT FDA, THIS MDR IS BEING SUBMITTED FOR CORRECTION AS EXPLAINED TO THE AGENCY IN A (B)(4) 2011 LETTER ADDRESSED TO (B)(6).

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1071713) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED THAT ON HE RECEIVED READINGS OF 74MG/DL AND 161MG/DL ON HIS FS LITE METER AND AS A RESULT HE REPORTEDLY SELF-TREATED WITH 50 UNITS OF INSULIN. CUSTOMER FURTHER REPORTED HE EXPERIENCED BOTH A LOSS OF CONSCIOUSNESS AND SEIZURE HOWEVER, DURING TROUBLESHOOTING THE CUSTOMER HUNG UP AND THE MEDICAL SURVEY WAS NOT COMPLETED. THE DATE OF THE MEDICAL EVENT IS UNKNOWN. UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO CLARIFY THE MEDICAL EVENT. NO THIRD PARTY INTERVENTION OR DIAGNOSIS WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1071713

    Patients

    Seq Age Sex Outcome Treatment
    1 Other