BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1142758 · Received August 27, 2008

    Report

    Report Number
    2939301-2008-01944
    Event Type
    Injury
    Date Received
    August 27, 2008
    Report Date
    August 22, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVAL, 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 (LFS) ALLEGING THAT SHE HAD A CALCODE ISSUE WITH A ONE TOUCH METER. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON AN UNSPECIFIED DATE/TIME THREE WEEKS PRIOR TO CONTACTING LFS ON THE SAME DAY. THE PT ALLEGED THAT SHE WAS UNABLE TO CODE THE METER. THE PT DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS A RESULT OF THE ALLEGED METER ISSUE. ON AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED ISSUE BEGAN, THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF BLURRY VISION AND DIZZINESS. THE PT DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER AND WAS NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: THE PT'S TESTING FREQUENCY, HER MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHAT ACTIONS THE PT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED, AND IF THE PT STILL TESTED HER BLOOD GLUCOSE DURING THE TIME OF CONCERN WITH THE REPORTED METER. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT THE PT'S LAST BLOOD GLUCOSE READING WAS BEFORE THE ALLEGED METER ISSUE BEGAN, WHEN THE LAST RESULT WAS OBTAINED, AND IF THE PT ASSOCIATED THE BLURRY VISION TO HIGH OR LOW BLOOD GLUCOSE. THE REPORTED METER ISSUE WAS RESOLVED WITH TROUBLESHOOTING/TRAINING. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening