BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1480728 · Received July 22, 2009

    Report

    Report Number
    2954323-2009-01296
    Event Type
    Malfunction
    Date Received
    July 22, 2009
    Date of Event
    June 11, 2009
    Report Date
    July 22, 2009
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    RETAIN SAMPLES FROM TEST STRIP LOT 0822524 HAVE BEEN TESTED AND ONE OF EIGHT RETAIN VIALS WAS CONFIRMED TO ALSO PRODUCE LOW RESULTS WITH CONTROL SOLUTION TESTING. FURTHER OBSERVATION OBSERVED A SCRATCH IN THE CHANNEL OF THE CARBON SIDE OF THE STRIP. THE SCRATCH COMPLETELY SEVERS THE CHANNEL CAUSING AN ELECTRICAL "OPEN". THE LOCATION OF THE SCRATCH LEAVES HALF OF THE CARBON AREA TO CONDUCT CHARGE DURING THE REACTION, POTENTIALLY RESULTING IN A LOW READING. THESE ERRONEOUS RESULTS MAY OCCUR IN THE "C" ZONE OF THE PARKES ERROR GRID, AND AS SUCH, HAVE THE POTENTIAL TO BE CLINICALLY SIGNIFICANT. REMEDIAL ACTION WAS REPORTED TO THE OFFICE ON 10 JUN 2009.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ADC METER RESULTS OF 82MG/DL TAKEN AT 0800, 74 MG/DL TAKEN AT 1330 AND 68 MG/DL TAKEN AT 1930 IN 2009. THE CUSTOMER STATED ALL OF THE READINGS WERE LOWER THAN SHE FELT SHE WAS. SHE STATED SHE EXPERIENCED A MEDICAL EVENT THAT MORNING WHERE SHE FELT "FUNNY" AFTER EATING AND TOOK INSULIN. SHE THEN TESTED AND "IT READ LOW" (NO SPECIFIC READING REPORTED). NO THIRD PARTY MEDICAL INTERVENTION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE GLUCOSE STRIPS LFR ABBOTT DIABETES CARE INC, USA NI 0822524

    Patients

    Seq Age Sex Outcome Treatment
    1 NI