BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1192401 · Received October 15, 2008

    Report

    Report Number
    2939301-2008-02541
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 EVALUATED THEM AND, IF EITHER THE METER, STIRPS, 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 ALLEGING THAT A ONE TOUCH ULTRA METER DID NOT GIVE HER A NUMERIC BLOOD GLUCOSE READING. THE PATIENT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON THE SAME DAY, AT 12:30 PM. THE PATIENT CLAIMED THAT THE METER COUNTED DOWN DURING A BLOOD GLUCOSE TEST BUT AT THE END OF THE COUNTDOWN, JUST SHOWED A "DIRECTION ARROW" POINTING TO THE LEFT. THE PATIENT DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS A RESULT OF THE ALLEGED METER ISSUE. THE PATIENT STATED THAT SHE DID NOT EAT OR TAKE HER MEDICATION SINCE SHE DID NOT KNOW IF SHE WAS HIGH OR LOW. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF SHAKINESS. THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER AND WAS NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. WHILE SPEAKING TO THE ONE TOUCH CUSTOMER ADVOCATE (OTCA), THE PATIENT PERFORMED A BLOOD GLUCOSE TEST AND GOT A METER READING OF "186 MG/DL." IT IS NOT KNOWN IF THE PATIENT WAS SYMPTOMATIC AT THE TIME THE RESULT WAS OBTAINED. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. AS A RESULT OF THE METER ISSUE, THE PATIENT MENTIONED THAT SHE HAD NOT EATEN OR TAKEN HER MEDICATION SINCE SHE DID NOT KNOW WHAT HER BLOOD GLUCOSE LEVEL WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2801680

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening