BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1013950 · Received March 14, 2008

    Report

    Report Number
    2939301-2008-00310
    Event Type
    Injury
    Date Received
    March 14, 2008
    Report Date
    February 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER METER, STRIPS, AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER, STRIPS, OR CONTROL SOLUTION 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/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER WAS READING INACCURATELY. IT IS NOT CLEAR IF THE PATIENT WAS ALLEGING AN INACCURACY HIGH OR LOW. BASED ON THE INFORMATION PROVIDED, THE REPORTED METER ISSUE BEGAN ON THE SAME DAY, AT 1:30 AM. BEFORE THE ISSUE STARTED, THE PATIENT HAD SYMPTOMS OF FEELING SICK, SWEATY, AND DISORIENTED. THE PATIENT TESTED HER BLOOD GLUCOSE AND GOT A RESULT OF "110 MG/DL". THE PATIENT DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS RESULT OF THE ALLEGED METER ISSUE. THE PATIENT WAS FEELING WEAK AND FELL. WITHIN 10-30 MINUTES OF OBTAINING THE METER RESULT OF "110 MG/DL", THE PATIENT'S BLOOD GLUCOSE WAS TESTED ON AN EMT METER AND A RESULT OF "24 MG/DL" WAS OBTAINED. THE PATIENT WAS TREATED WITH FOOD AND/OR A BEVERAGE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HER MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHAT DATE/TIME THE SYMPTOMS DEVELOPED, WHAT ACTIONS THE PATIENT TOOK BEFORE DEVELOPING THE SYMPTOMS, AND WHAT METER READINGS THE PATIENT GOT BEFORE AND DURING THE TIME SHE HAD THE SYMPTOMS. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PATIENT WOULD HAVE TAKEN ANY ACTIONS IF SHE HAD OBTAINED A BLOOD GLUCOSE READING THAT CORRELATED WITH HER SYMPTOMS SUGGESTIVE OF LOW BLOOD GLUCOSE, AND IF THE PATIENT ATE DINNER OR A SNACK THE NIGHT BEFORE THE EVENT. THE PATIENT ADMITTED THAT SHE HAD NEVER SET THE METER'S CODE EVER SINCE SHE GOT THE METER ABOUT A YEAR AND A HALF AGO. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED SHE HAD THE METER FOR OVER A YEAR AND HAD NEVER CODED THE DEVICE. THE PATIENT ALLEGED THAT SHE OBTAINED A NORMAL RANGE BLOOD GLUCOSE READING ON THE LFS PRODUCT THAT DID NOT CORRELATE WITH HER SYMPTOMS THAT SUGGESTED HYPOGLYCEMIA AND WITH A HYPOGLYCEMIC READING ON A PARAMEDIC'S METER. THE PATIENT CLAIMS SHE WAS TREATED WITH FOOD AND/OR BEVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2705324

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R