BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1030149 · Received April 15, 2008

    Report

    Report Number
    2939301-2008-00570
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 23, 2008
    Report Date
    March 25, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE 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 2 METER READ INACCURATELY HIGH. THE PT TESTS HIS BLOOD GLUCOSE ONCE A DAY. HE MANAGES HIS DIABETES VIA PILLS, DIET, AND EXERCISE. ON A WEEK EARLIER, THE PT CLAIMED THAT HE GOT A RESULT OF "HI" ON THE REPORTED METER AT 9:04 PM. ACCORDING TO THE OWNER'S MANUAL, A RESULT OF "HI" INDICATES A POSSIBLE BLOOD GLUCOSE LEVEL EXCEEDING 600 MG/DL. AS A RESULT OF THE ALLEGED METER ISSUE, THE PT ADMINISTERED SELF-CARE BY TAKING AN INCREASED DOSE OF DIABETES MEDICATION. THE PT TOOK 2 PILLS OF METFORMIN (500 MG) AND 2 "GLUCOSE PILLS OF 10 GRAMS." AT 10:30 PM, THE SAME EVENING, THE PT RECEIVED ASSISTANCE IN AN ( ER). HIS BLOOD GLUCOSE WAS TESTED ON AN ER/HOSPITAL METER AND A RESULT OF "60 MG/DL" WAS OBTAINED. THE PT WAS TREATED WITH FOOD AND/OR A BEVERAGE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: WHEN THE PT TYPICALLY TESTS DURING THE DAY, WHAT HIS NORMAL BLOOD GLUCOSE LEVELS ARE, AND WHAT HIS LAST BLOOD GLUCOSE READING WAS BEFORE THE "HI" RESULT WAS OBTAINED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT "GLUCOSE PILLS" THE PT TOOK, THE DETAILS OF HIS MEDICATION REGIMEN, WHAT HIS HOSPITAL DIAGNOSIS WAS, AND IF HE TOOK ANY OTHER ACTIONS RELATED TO DIABETES TREATMENT BEFORE OR AFTER THE RESULT OF "HI" WAS OBTAINED. THE PT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PT WAS OBTAINING BLOOD SAMPLES FROM HIS FINGERS AND CLEANING THE PUNCTURE SITES CORRECTLY. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT HE OBTAINED A BLOOD GLUCOSE READING OF "60 MG/DL" AND RECEIVED TREATMENT SUGGESTIVE FOR HYPOGLYCEMIA AFTER OBTAINING AN ALLEGED INACCURATE HIGH METER RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2770011

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R