BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MICRO-DRAW TEST STRIP

    MDR report key: 1005086 · Received February 28, 2008

    Report

    Report Number
    1832816-2008-00008
    Event Type
    Injury
    Date Received
    February 28, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 1, 2008
    Manufacturer
    PARLEX (EUROPE), LTD.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL PRODUCT WAS NOT RETURNED FOR TESTING. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE TESTED AND PERFORMED TO SPECIFICATION.

    Description of Event or Problem · 1

    CALLER INDICATED THE ADVANCE METER WAS READING HIGH. SHE TESTED HERSELF AT 12:30 AND IT READ "HI". SHE TOOK INSULIN RIGHT AWAY. AROUND 1:30 SHE STARTED FEELING HUNGRY, SHAKING AND SHE KNEW HER BG WAS DROPPING TOO LOW. AT 1:45 SHE WAS IN A RESTAURANT SO SHE ATE A BUNCH OF CANDY, CAKE, COOKIES, COKE, PIZZA TO TRY TO GET HER BG UP. BY 2:30 SHE FELT BETTER BUT STARTED TO GET A LITTLE SLEEPY LIKE MAYBE HER BG WENT TOO HIGH. SHE DID NOT TEST WITH HER MACHINE AGAIN BECAUSE SHE DIDN'T THINK THE MACHINE WAS WORKING. THE MACHINE HAS BEEN DOING THESE KINDS OF THINGS FOR A WHILE NOW AND SHE NO LONGER TRUSTS IT. IN THE PAST SHE'S DONE BACK TO BACK READINGS AND GOTTEN 77, 320, 500 WITHIN A COUPLE OF MINUTES. THE METER IS VERY ERRATIC AND ALMOST ALWAYS TOO HIGH. SHE HAS SOUGHT HELP FROM HER DOCTOR AND THE PHARMACY - WHO WERE BOTH PUZZLED AND RECOMMENDED SHE CALL US. WHEN SHE FIRST CALLED US WE REPLACED THE METER BUT THAT DID NOT SOLVE THE PROBLEM. I WILL REPLACE METER, 12 BOXES OF STRIPS WITH THE SAME LOT, AND CONTROL SOLUTION. I WENT OVER TECHNIQUE WITH HER AND SHE HAS A FINE TECHNIQUE. SHE CLAIMS THE CONTROL SOLUTION ALWAYS READS OVER 200 BUT I DISCOVERED SHE WAS NOT PUTTING METER IN CS MODE AND WHEN YOU WALKED HER THROUGH SOME TESTS THEY CAME OUT 104 AND 105 WHICH IS WELL WITHIN RANGE. SHE HAS BEEN HOSPITALIZED FOR KETOACIDOSIS TWICE RECENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE MICRO-DRAW TEST STRIP BLOOD GLUCOSE TEST STRIP NBW PARLEX (EUROPE), LTD. 410050 02147A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention