BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1358163 · Received April 7, 2009

    Report

    Report Number
    2939301-2009-02228
    Event Type
    Injury
    Date Received
    April 7, 2009
    Date of Event
    March 28, 2009
    Report Date
    March 28, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2009, THE LAY-USER/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRASMART METER READ INACCURATELY HIGH. THE PT TREATS HER DIABETES WITH GLARGINE (LANTUS INSULIN) AND METFORMIN. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED TWO DAYS PRIOR, AT 1:30 AM. THE PT REPORTED METER READINGS OF "241, 197, AND 137 MG/DL" BUT IT IS NOT KNOWN WHAT DATES/TIMES THE REPORTED RESULTS WERE OBTAINED. ON ORIGINAL DATE, AT 1:20 AM, THE PT'S BLOOD GLUCOSE WAS TESTED ON AN UNIDENTIFIED DEVICE AND A RESULT OF "170 MG/DL" WAS OBTAINED. AT 1:30 AM, THE PT CALLED A NURSE. THE NURSE ADVISED THE PT TO CALL HER DOCTOR AND TO ALSO TAKE A "GLUCOSE TABLET." IT IS NOT CLEAR IF THE PT WAS INSTRUCTED TO TAKE A TABLET TO RAISE HER BLOOD GLUCOSE. THE PT DENIED HAVING ANY SYMPTOMS OF HIGH/LOW BLOOD GLUCOSE DURING THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: THE PATIENT'S TESTING FREQUENCY, WHEN THE REPORTED RESULTS WERE OBTAINED, WHAT DEVICE WAS USED TO OBTAIN THE READING OF "170 MG/DL," AND WHAT TYPE OF "GLUCOSE TABLET" THE PT WAS ADVISED TO TAKE. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT ACTIONS THE PT TOOK BEFORE CALLING THE NURSE , WHAT THE PT'S DOCTOR ADVISED HER TO DO, WHAT ACTIONS THE PT TOOK IN RESPONSE TO THE ALLEGED METER ISSUE, AND WHY THE PT WAS ADVISED TO TAKE THE GLUCOSE TABLET. THE PT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PT WAS OBTAINING BLOOD SAMPLES FROM HER FINGERS AND CLEANING THE PUNCTURE SITES CORRECTLY. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE WAS ADVISED BY A NURSE TO TAKE A "GLUCOSE TABLET" AFTER THE METER STARTED READING INACCURATELY HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2882786

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R