BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1422840 · Received July 27, 2009

    Report

    Report Number
    2939301-2009-04623
    Event Type
    Injury
    Date Received
    July 27, 2009
    Report Date
    July 9, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2009, THE LAY-USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA 2 METER READ INACCURATELY HIGH AND ERRATICALLY. THE PATIENT ALSO ALLEGED THAT SHE HAD A BENT ONE TOUCH ULTRA TEST STRIP ISSUE. THE PATIENT MANAGES HER DIABETES WITH DIET AND EXERCISE. THE PATIENT INDICATED THAT THE ALLEGED METER AND TEST STRIP ISSUES STARTED SIX DAYS PRIOR, AT UNKNOWN TIMES. THE FOLLOWING METER READINGS WERE REPORTED AS BEING ALLEGEDLY HIGH: "156, 158, 121, 123, 179, 184, 127, 127, 125, 134, 138, 124, 117, 113, 123, 141, 141, 151, 146, 125, 128, 118, 138, 147, AND 158 MG/DL." IN ANOTHER INSTANCE, THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "179 AND 184 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF <=20% AND/OR <=20 MG/DL. THE PATIENT DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS A RESULT OF THE ALLEGED ISSUES. THREE OR FOUR DAYS AFTER THE ALLEGED ISSUES BEGAN, THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF IRRITABILITY AND SWEATING. SHE DENIED RECEIVING TREATMENT DURING THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, WHAT TIMES THE ALLEGED ISSUES BEGAN, WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE SYMPTOMS STARTED, AND METER READING(S) SHE OBTAINED BEFORE AND AFTER THE SYMPTOMS BEGAN, AND WHEN THE RESULTS (IF ANY) WERE OBTAINED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT DATES/TIMES THE REPORTED RESULTS WERE OBTAINED, WHEN THE SYMPTOMS WERE RELIEVED, AND IF THE PATIENT WAS STILL ABLE TO TEST ALTHOUGH THE TEST STRIPS WERE REPORTEDLY BENT. THE PATIENT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PATIENT WAS OBTAINING BLOOD SAMPLES FROM HER FINGERS AND CLEANING THE PUNCTURE SITES CORRECTLY. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE METER ALLEGEDLY STARTED TO READ INACCURATELY HIGH AND THE BENT TEST STRIP ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2921729

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening