BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1491013 · Received September 28, 2009

    Report

    Report Number
    2939301-2009-05971
    Event Type
    Injury
    Date Received
    September 28, 2009
    Date of Event
    September 11, 2009
    Report Date
    September 11, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 EVALUATED 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/REPORTED CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRALINK METER READ INACCURATELY. THE REPORTER CALLED LFS ON BEHALF OF HER DAUGHTER (THE PT). THE PT TESTS HER BLOOD GLUCOSE 4 OR MORE TIMES A DAY. SHE MANAGES HER DIABETES WITH HUMALOG INSULIN VIA INSULIN PUMP. THE REPORTER CLAIMED THAT THE ALLEGED ISSUE STARTED AT 6:06 AM. SHE REPORTED BLOOD GLUCOSE OF "231, 160, AND 99 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE REPORTER STATED THAT SHE DID NOT KNOW WHICH RESULT OF THE THREE METER READINGS WAS SUED TO CALCULATE HER DAUGHTER'S INSULIN DOSAGE. ABOUT 10:00 AM THAT SAME MORNING, THE REPORTER CLAIMED THAT THE PT DEVELOPED LOW BLOOD GLUCOSE SYMPTOMS OF SHAKINESS. WHILE FEELING SHAKY, THE PT TESTED HER BLOOD GLUCOSE WITH THE REPORTED METER AND GOT "49 MG/DL." THE PT TREATED HERSELF WITH JUICE AND GLUCOSE TABLETS. THE SELF-TREATMENT HELPED TO RELIEVE HER SYMPTOMS. ACCORDING TO THE REPORTER, THE PT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PT 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 REPORTER CLAIMED THAT THE PT 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 ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2903125

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening| R