BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC ENAHANCED METER

    MDR report key: 1081633 · Received July 22, 2008

    Report

    Report Number
    2939301-2008-01472
    Event Type
    Injury
    Date Received
    July 22, 2008
    Report Date
    July 15, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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

    ON JULY 15, 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH BASIC METER HAD AN "APPLY SAMPLE" ISSUE. THE PATIENT INDICATED THAT THE ALLEGED METER ISSUE STARTED AROUND THREE MONTHS EARLIER. AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT ADMINISTERED SELF-CARE BY INCREASING HIS INSULIN DOSAGE(S) FROM 40 UNITS TO 60 UNITS. IT IS NOT KNOWN IF THE PATIENT TOOK ONE INCREASED DOSE OR MULTIPLE INCREASED DOSES. ON APPROX TWO WEEKS PRIOR TO ORIGINAL DATE, THE PATIENT RECEIVED ASSISTANCE IN AN EMERGENCY ROOM (ER). THE PATIENT'S BLOOD GLUCOSE WAS TESTED ON ER/HOSPITAL METER. THE PATIENT CLAIMED THAT HIS BLOOD GLUCOSE LEVEL ON THE ER METER WAS 800 MG/DL." THE PATIENT WAS REPORTEDLY TREATED WITH INSULIN (UNKNOWN TYPE/DOSAGES). IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HIS DIABETES MANAGEMENT AND MEDICATION REGIMENS, AND WHAT HIS LAST BLOOD GLUCOSE RESULT WAS BEFORE THE ALLEGED METER ISSUE BEGAN. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PATIENT HAD ANY SYMPTOMS DURING THE TIME OF CONCERN, IF HE WAS HOSPITALIZED AND WHAT HIS HOSPITAL DIAGNOSIS WAS. THE PATIENT WAS NOT USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE ISSUE WAS RESOLVED AFTER THE PATIENT TESTED WITH A NEW TEST STRIP AND A CORRECT TESTING TECHNIQUE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HIS BLOOD GLUCOSE LEVEL REACHED "800 MG/DL" IN A HOSPITAL DURING THE TIME THAT HE WAS UNABLE TO TEST WITH THE ALLEGED METER. THE PATIENT CLAIMED THAT THE METER ISSUE STARTED ABOUT 2 MONTHS BEFORE HE RECEIVED TREATMENT IN THE HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R