BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2248486 · Received September 14, 2011

    Report

    Report Number
    2954323-2011-04484
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 16, 2011
    Report Date
    November 23, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. ADDITIONALLY: MULTIPLE ATTEMPTS HAVE BEEN MADE, WITHOUT SUCCESS, TO CLARIFY THE INCONSISTENCIES REPORTED IN THIS CASE.

    Additional Manufacturer Narrative · 1

    THIS IS A CORRECTION REPORT. DEVICE EVALUATED BY MANUFACTURER: ON FOLLOW-UP REPORT #1 SUBMITTED 09 NOVEMBER 2011 SHOULD HAVE HAD SELECTED "NOT RETURNED TO MANUFACTURER." THE CORRECT SELECTION IS REFLECTED ON THIS REPORT.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1151207) 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 REPORTED THAT APPROXIMATELY (B)(6) PRIOR TO CALLING ON (B)(6) 2011 SHE RECEIVED AN UNSPECIFIED "LOW" READING ON HER ADC BLOOD GLUCOSE METER AND NOTED EXPERIENCING VERTIGO, DIAPHORESIS AND TREMULOUSNESS. PARAMEDICS WERE CALLED AND ADMINISTERED AN UNSPECIFIED AMOUNT OF INSULIN. CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTHCARE FACILITY, WHERE A READING OF 400 MG/DL WAS RECEIVED ON THE HOSPITAL METER. CUSTOMER DID NOT RECEIVE ANY ADDITIONAL TREATMENT AT THE HOSPITAL. CUSTOMER REPORTEDLY SELF-TREATED BY DRINKING THE WATER FROM A "(B)(6)". 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 1151207

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention