BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1063374 · Received June 19, 2008

    Report

    Report Number
    2939301-2008-01130
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 7, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS 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 (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS POWERING OFF DURING USE. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT ON JUNE 17, 2008 AND OBTAINED THE FOLLOWING INFO. THE PT REPORTED THAT THE ALLEGED ISSUE BEGAN FOUR DAYS PRIOR TO CONTACTING LFS. ON AN UNSPECIFIED TIME ON FOUR DAYS PRIOR TO ORIGINAL DATE WHILE AT WORK, THE PT ATTEMPTED TO TEST ON THE SUBJECT METER, BUT CLAIMS SHE WAS UNABLE TO GET A READING. THE PT REPORTED THAT THE METER POWERED ON WHEN THE STRIP WAS INSERTED, BUT ONCE THE BLOOD SAMPLE WAS APPLIED TO THE TEST STRIP, THE METER WOULD POWER OFF AFTER COUNTING DOWN INSTEAD OF DISPLAYING A RESULT. IT IS UNCLEAR WHAT ACTIONS THE PT TOOK REGARDING HER DIABETES MGMT AT THE TIME SHE WAS UNABLE TO OBTAIN A READING. SOMETIME AFTER THE REPORTED ISSUE BEGAN, THE PT REPORTED SHE WENT "HYPO" AS A RESULT OF NOT BEING ABLE TO TEST AT WORK. THE PT MENTIONED SHE STARTED FEELING "DIZZY AND DISORIENTED" WHEN SHE GOT HOME FROM WORK. THE PT TREATED SELF WITH ORANGE JUICE AND CONFIRMED SHE FELT BETTER AFTERWARDS. THE PT REPORTED TO THE CCA THAT SHE DID TEST ON ANOTHER METER AT THE TIME OF SYMPTOMS BUT OBTAINED A READING OF "42 MG/DL". IT IS UNCLEAR IF THIS RESULT WAS OBTAINED PRIOR TO, DURING OR AFTER THE SYMPTOMS DEVELOPED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THERE WAS NO MISUSE TO THE SUBJECT METER. HOWEVER, THE PT WAS UNWILLING/UNABLE TO CONFIRM IF THE BATTERY HAD BEEN REPLACED PER THE OWNER'S BOOKLET. REPLACEMENT PRODS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA 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 2823854

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R