BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1222084 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02919
    Event Type
    Injury
    Date Received
    November 4, 2008
    Report Date
    October 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER HAD AN "APPLY SAMPLE" ISSUE. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON THREE DAYS EARLIER, AT 4:00 AM. ON AN UNK DATE/TIME AFTER THE ALLEGED ISSUE BEGAN, THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF FEELING HOT. ON OCT 16, 2008, AT 7:07 AM, THE PT MENTIONED THAT SHE RECEIVED ASSISTANCE IN AN EMERGENCY ROOM (ER) BECAUSE THE METER DID NOT COUNT DOWN THAT SAME MORNING. THE PT'S BLOOD GLUCOSE WAS TESTED ON AN ER/HOSP METER BUT SHE WAS UNABLE TO RECALL WHAT READING WAS OBTAINED. THE PT MENTIONED, HOWEVER, THAT A DOCTOR REPORTEDLY INFORMED HER THAT IT WAS HIGH. THE PT WAS TREATED WITHIN IV FLUIDS. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: THE PT'S TESTING FREQUENCY, HER MEDICATION AND DIABETES MGMT REGIMENS, WHAT HER LAST BLOOD GLUCOSE READING WAS BEFORE THE ALLEGED METER ISSUE BEGAN, WHAT ACTIONS THE PT TOOK IN RESPONSE TO THE METER ISSUE, AND WHAT ACTIONS THE PT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED. THE PT WAS REPORTEDLY NOT USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE ALLEGED ISSUE WAS RESOLVED WITH TRAINING/TROUBLESHOOTING. 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 RECEIVED TREATMENT FOR HYPERGLYCEMIA 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 2839064

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R