BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2675904 · Received July 31, 2012

    Report

    Report Number
    2954323-2012-06427
    Event Type
    Injury
    Date Received
    July 31, 2012
    Date of Event
    July 16, 2012
    Report Date
    July 16, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 (B)(4) 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

    THIS IS AN INITIAL REPORT. THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. (B)(4) IT SHOULD BE NOTED: CUSTOMER DECLINED TO PROVIDE HIS WEIGHT. ADDITIONALLY, THE ACTUAL DATE WHEN THE EVENT OCCURRED IS UNKNOWN. THE DATE LISTED IN THIS REPORT IS THE DATE WHEN ABBOTT DIABETES CARE, INC. BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT APPROXIMATELY 8 WEEKS PRIOR TO CALLING CUSTOMER SERVICE ON (B)(6) 2012 WHILE ON VACATION HE PERFORMED A TEST USING HIS ADC BLOOD GLUCOSE METER AND RECEIVED A READING OF 12 MMOL/L (216 MG/DL), WHICH WAS HIGHER THAN HE FELT. CUSTOMER FURTHER REPORTED THAT 30 MINUTES LATER HE BEGAN TO EXPERIENCE "SHAKING". PARAMEDICS WERE CALLED AND A NEW READING OF 63 MG/DL (3.5 MMOL/L) WAS OBTAINED. IT IS UNKNOWN IF THIS NEW READING WAS OBTAINED ON THE ADC BLOOD GLUCOSE METER OR THE PARAMEDIC'S UNKNOWN BRAND OF METER. CUSTOMER WAS TREATED WITH GLUCOSE VIA INTRAVENOUS INFUSION AND TRANSPORTED TO A LOCAL HEALTHCARE FACILITY. AT THE HOSPITAL CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH ADDITIONAL GLUCOSE VIA IV. CUSTOMER DID NOT TAKE ANY ACTIONS BASED UPON THE INITIAL READING OF 12 MMOL/L (216 MG/DL), AND NOTED JUST TAKING HIS "USUAL (UNSPECIFIED) MEDICATIONS". 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 FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1258960

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R