BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1070528 · Received July 2, 2008

    Report

    Report Number
    2939301-2008-01262
    Event Type
    Injury
    Date Received
    July 2, 2008
    Date of Event
    June 15, 2008
    Report Date
    June 20, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 JUNE 20, 2008, THE LAY-USER/REPORTER CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER HAD AN "APPLY SAMPLE" ISSUE. THE PATIENT TESTS HER BLOOD GLUCOSE 3 TIMES A DAY. SHE TESTS BEFORE EACH MEAL. SHE ALSO TAKES SET DOSES OF GLUCOPHAGE AND ACTOS. THE REPORTER INDICATED THAT THE ALLEGED METER ISSUE STARTED ON FIVE DAYS PRIOR, DURING THE MORNING TIME. THE REPORTER MENTIONED THAT DURING THE TIME OF CONCERN, THE PATIENT TOOK HER MEDICATIONS "SPORADICALLY" SINCE SHE REPORTEDLY DID NOT KNOW WHAT HER BLOOD GLUCOSE LEVELS WERE. ON AN UNSPECIFIED DATE/TIME AFTER THE ISSUE BEGAN, THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS OF FEELING TIRED, NERVOUS, CONFUSED, AND THIRSTY. ALSO, THE PATIENT'S FEET WERE REPORTEDLY "TINGLING." WHEN THE PATIENT CALLED THE REPORTER TO TELL HIM ABOUT THE METER ISSUE, HE ADVISED HER TO CONTINUE TO TAKE HER MEDICATIONS AS PRESCRIBED AND TO DRINK ORANGE JUICE. THE PATIENT DID NOT RECEIVE MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER. THE REPORTER DID NOT HAVE THE METER OR REAGENTS FOR TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THE COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT 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 77 YR Life Threatening