BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1001984 · Received February 21, 2008

    Report

    Report Number
    2939301-2008-00213
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE REPORTER/PT'S MOTHER CONTACTED LIFESCAN ON BEHALF OF THE LAY USER/PT ALLEGING THAT THE PT'S ONE TOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. THE FOLLOWING INFO WAS OBTAINED FROM THE RECORDED CALL BETWEEN THE CUSTOMER CARE ADVOCATE (CCA) AND THE REPORTER. THE REPORTER CANNOT BE REACHED FOR MORE INFO SINCE A PHONE NUMBER WAS NOT PROVIDED. THE PT'S MOTHER INDICATED THAT "ABOUT 3 WEEKS AGO" THE PT'S BLOOD GLUCOSE WAS "130 MG/DL" ON HIS METER. SHE NOTICED THAT HE WAS SLURRING HIS WORDS BEFORE HE TESTED ON THE METER BUT THE PT TOLD HIS MOM THAT HIS BLOOD GLUCOSE LEVELS WERE OKAY. SHE FELT THAT SOMETHING WAS WRONG AND THAT THE METER WAS READING INACCURATELY HIGH. SHE GAVE HIM "LIQUID" TO BRING HIS BLOOD GLUCOSE LEVELS UP, BUT THEN HE REPORTEDLY "FELL BACK." THE PT'S MOTHER CALLED THE EMERGENCY SERVICES SINCE SHE FELT SHE WAS UNABLE TO GET HIS BLOOD GLUCOSE LEVELS BACK UP. WHEN THE EMS ARRIVED, THE PT'S BLOOD GLUCOSE WAS "6 MG/DL" ON THE EMS METER AND HE WAS TREATED WITH IV GLUCOSE. SHE CLAIMED THAT "130 AND 6 MG/DL" TEST RESULTS WERE OBTAINED WITHIN LESS THAN 10 MINUTES OF EACH OTHER. IT WOULD BE HELPFUL TO KNOW HOW OFTEN THE PT TESTS ON HIS METER AND IF HE TAKES ANY DIABETES MEDICATIONS. IT WOULD ALSO BE HELPFUL TO KNOW WHAT EVENTS OCCURRED BEFORE HE TESTED ON HIS METER, SUCH AS HIS ACTIVITY LEVELS, MEDICATIONS, MEALS, AND PREVIOUS METER READINGS. THE REPORTER DID NOT HAVE THE TESTING SUPPLIES WITH HER DURING THE CALL BUT CLAIMED THAT THE METER WAS PROPERLY CODED AND SHE ALSO USED THE "LIQUID" TO TEST THE METER. THE CCA NOTED THAT THE METER WAS CORRECTLY SET TO "MG/DL," AN APPROVED SAMPLE SOURCE WAS USED, AND THE CORRECT TESTING/CLEANING TECHNIQUES WERE USED. REPLACEMENT PRODUCTS WERE SENT TO THE PT. BASED ON THE PROVIDED INFO, THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMED THE PT REQUIRED EMS TREATMENT FOLLOWING A RESULT OF 130 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R