BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1577196 · Received January 13, 2010

    Report

    Report Number
    2954323-2010-00049
    Event Type
    Injury
    Date Received
    January 13, 2010
    Date of Event
    December 29, 2009
    Report Date
    July 14, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED AND NO TEST STRIP LOT WAS REPORTED WITH THIS COMPLAINT, A DHR OF THE METER WAS REQUESTED. THE DEVICE HISTORY REPORT FOR METER (B) (4) INDICATED THE DEVICE WAS PERFORMING WITHIN ITS PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO ITS RELEASE. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND A FINAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION RESULTS ARE AVAILABLE. CUSTOMER'S PRODUCT HAS BEEN REPLACED WITH AN XCEED METER AND TEST STRIPS THAT ARE NOT SUSCEPTIBLE TO INTERFERENCE WITH GLUCOSE DEHYDROGENASE PYRROLOQUINOLINE QUINONE. NOTE: FALSELY ELEVATED BLOOD GLUCOSE RESULTS CAN OCCUR WHEN USING GDH-PQQ (GLUCOSE DEHYDROGENASE PYRROLOQUINOLINE QUINONE) GLUCOSE TEST STRIPS WITH PATIENTS WHO ARE RECEIVING THERAPEUTIC PRODUCTS CONTAINING NONGLUCOSE SUGARS SUCH AS EXTRANEAL (ICODEXTRIN) PERITONEAL DIALYSIS SOLUTION.

    Additional Manufacturer Narrative · 1

    THE "DATE RECEIVED BY MANUFACTURER" ON FOLLOW-UP #1 REPORT SHOULD HAVE REFLECTED THE DATE OF (B)(6) 2010. 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).

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THAT AN ADC CUSTOMER RECEIVED A METER READING OF 170MG/DL HOWEVER, AT THE TIME THE READING WAS OBTAINED THEY EXPERIENCED HYPOGLYCEMIA, MALAISE AND REPORTEDLY LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED AND UPON ARRIVAL AT THE HOSPITAL A METER READING OF 40MG/DL WAS OBTAINED. IT IS UNKNOWN WHAT METER WAS USED TO OBTAIN THE SECOND READING. THE REPORT STATED CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND GIVEN A 'SWEETENED PERFUSION' (EXACT SOLUTION TYPE NOT REPORTED). CUSTOMER REMAINED IN THE HOSPITAL THROUGH THE FOLLOWING DAY. NO ADDITIONAL INFORMATION REGARDING THE MEDICAL EVENT WAS REPORTED. THE PHARMACIST INFORMED ADC THAT THE CUSTOMER WAS CURRENTLY ON DIALYSIS AND USING EXTRANEAL (ICODEXTRIN) PERITONEAL DIALYSIS SOLUTION. 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 FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention