BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1222083 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02920
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 17, 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, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, BUT HADS 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/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER HAD A MISSING SEGMENTS ISSUE. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON FOUR DAYS EARLIER. AS A RESULT OF THE ALLEGED METER ISSUE, THE PT REPORTEDLY SKIPPED OR STOPPED TAKING HER INSULIN. IT IS NOT KNOWN IF THE PT TRIED TO INTERPRET ANY METER READINGS WITH MISSING SEGMENTS. THE PT REPORTEDLY SKIPPED/STOPPED TAKING 4 UNITS OF REGULAR INSULIN AND 6 UNITS OF "CLOUD" INSULIN. ON TWO DAYS PRIOR TO ORIGINAL DATE, AT 3:AM, THE PT REPORTEDLY RECEIVED ASSISTANCE IN AN EMERGENCY ROOM (ER). THE PT'S BLOOD GLUCOSE WAS TESTED ON A HOSP METER AND A RESULT OF "639 MG/DL" WAS REPORTEDLY OBTAINED. THE PT CLAIMED THAT HE WAS TREATED WITH 6 UNITS OF REGULAR INSULIN AND 3 UNITS OF "CLOUDY" INSULIN. HE 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 PT'S TESTING FREQUENCY, HIS MEDICATION AND DIABETES MGMT REGIMENS, WHAT THE PT'S LAST BLOOD GLUCOSE READING WAS BEFORE THE ALLEGED METER ISSUE BEGAN, AND IF THE PT SKIPPED MORE THAN 1 DOSE OF EACH INSULIN DURING THE TIME OF CONCERN. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PT MODIFIED HIS DIET AFTER THE ALLEGED METER ISSUE BEGAN, IF THE PT CONTINUED TO TEST WITH THE REPORTED METER AFTER THE ISSUE STARTED, AND IF THE PT TRIED TO INTERPRET ANY METER READINGS WITH MISSING SEGMENTS. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT HE RECEIVED A READING OF "639 MG/DL" AND WAS TREATED WITH INSULIN IN AN ER AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2856005

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R