BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1081635 · Received July 22, 2008

    Report

    Report Number
    2939301-2008-01469
    Event Type
    Injury
    Date Received
    July 22, 2008
    Report Date
    July 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    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/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRA METER HAD A "SEGMENTS MISSING" ISSUE. THE PATIENT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON AN UNSPECIFIED DATE THE WEEK BEFORE SHE CALLED LFS ON THE SAME DAY. THE PATIENT DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS A RESULT OF THE ALLEGED METER ISSUE. SHE ALSO DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER. HOWEVER, THE PATIENT CLAIMED THAT ON AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED METER ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OF FEELING THIRSTY AND DIZZY. DURING THE TIME OF CONCERN, THE PATIENT WAS ABLE TO TEST HER BLOOD GLUCOSE ON HER HUSBAND'S UNIDENTIFIED METER. SHE REPORTEDLY GOT A RESULT OF "115 OR 120 MG/DL." IT IS NOT KNOWN IF THE PATIENT WAS SYMPTOMATIC WHEN SHE TESTED ON HER HUSBAND'S METER. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HER DIABETES MANAGEMENT AND MEDICATION REGIMENS, WHEN THE PATIENT OBTAINED THE METER RESULT ON HER HUSBAND'S METER IN RELATION TO WHEN SHE WAS SYMPTOMATIC, AND WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PATIENT TRIED TO INTERPRET HER METER READINGS WITH MISSING SEGMENTS, WHAT HER LAST BLOOD GLUCOSE READING WAS BEFORE THE REPORTED ISSUE BEGAN, AND WHAT DATE/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 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 2802996

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening