BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1211548 · Received October 22, 2008

    Report

    Report Number
    2939301-2008-02748
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REP (CSR) DOCUMENTATION AND RECORDED PHONE CONVERSATION. THE PT TESTS HER BLOOD GLUCOSE TWICE A DAY AND MANAGES HER DIABETES WITH PILL, DIET AND EXERCISE. BEFORE THE REPORTED ISSUE, THE PT STATED THAT SHE CORRECTED HER BLOOD GLUCOSE WITH NPH INSULIN ON A SLIDING SCALE, AND HER BLOOD GLUCOSE WOULD FALL BACK WITHIN THE NORMAL RANGE WHENEVER HER BLOOD GLUCOSE IS HIGH. HOWEVER, FOR ABOUT A MONTH NOW, THE PT STATED THAT HER METER WOULD READ EITHER "TOO HIGH OR TOO LOW". ON ONE OCCASION, THE PT GETS A "HIGH" READING, GIVES HERSELF THE SAME DOSE OF SLIDING INSULIN (NPH) TO CORRECT HER BLOOD SUGAR LEVEL AND WAS REPORTEDLY "SWEATING" AFTER THE CORRECTIVE INSULIN. IT WAS UNK WHAT THE PT DID TO TREAT HER SYMPTOMS. THE PT ALSO MENTIONED THAT THE METER WAS READING LOWER THAN THE HEALTHCARE PROFESSIONAL'S (HCP) METER. ON THE DAY BEFORE, BEFORE BEDTIME, THE PT TESTED ON THE SUBJECT METER AND IT GAVE A "109 MG/DL" BLOOD GLUCOSE RESULT. IN THE MORNING-BEFORE HAVING BREAKFAST-THE PT REPORTEDLY OBTAINED A "200 MG/DL" ON THE HCP'S METER. WHILE AT THE HCP'S CLINIC, THE PT MENTIONED THAT HER A1C TEST RESULT WAS "PERFECT" AND THERE WAS NO MENTIONING OF ANY OTHER TREATMENTS. THE REPORTED RESULTS OBTAINED ON BOTH METERS DO NOT MEET LFS ACCURACY TESTING CRITERIA. DURING TROUBLESHOOTING, IT WAS VERIFIED THAT THE CONTROL SOLUTION RESULT WAS WITHIN THE CONTROL SOLUTION RANGE; THEREFORE, INDICATING THAT THE METER WAS PROPERLY CALIBRATED AND GAVE THE CORRECT READINGS. THE UNIT OF MEASUREMENT WAS CORRECTLY SET TO MG/DL. THE TESTING AND CLEANING OF PUNCTURE SITES ARE CORRECT. THE PT'S PRODUCTS HAVE BEEN REPLACED. THERE WAS NO INDICATION THAT THE METER MALFUNCTIONED BECAUSE THE CONTROL SOLUTION WAS WITHIN RANGE. IN ADDITION, COMPARING METER READINGS TO NORMAL READINGS OR FEELINGS IS AN ANECDOTAL COMPARISON. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER ADMINISTERING INSULIN BASED ON THE METER READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2847901

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening