BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1392409 · Received May 20, 2009

    Report

    Report Number
    2939301-2009-03010
    Event Type
    Injury
    Date Received
    May 20, 2009
    Date of Event
    May 14, 2009
    Report Date
    May 15, 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 (LFS) ALLEGING THAT THE ONE TOUCH ULTRA METER IS GIVING INACCURATE ERRATIC READINGS. THIS COMPLAINT IS BEING CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE AS THE PATIENT COULD NOT BE CONTACTED TO OBTAIN MORE INFORMATION. A NO RESPONSE LETTER WAS SENT TO THE PATIENT. THE PATIENT DOES NOT KNOWN WHEN THE REPORTED ISSUE BEGAN. AT AN UNSPECIFIED DATE AND TIME, THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "122, 192, AND 228 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 20 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 DAY PRIOR AT 8 AM, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS DESCRIBED AS "SHAKY, BLOOD PRESSURE UP, SWEATY, AND FACE WAS RED". THE PATIENT PROMPTLY TOOK HER GLUCAGON MEDICATION AFTER THE REPORTED SYMPTOMS BEGAN. THE PATIENT DID NOT RECEIVE ANY MEDICAL INTERVENTION AT THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES MEDICATION REGIMEN AND TESTING FREQUENCY, THE DURATION OF THE SYMPTOMS, WHAT TREATMENT DID THE PATIENT RECEIVE IN ORDER FOR THE SYMPTOMS TO ABATE, COULD THE SYMPTOMS HAVE BEEN PREVENTED, WAS THE PATIENT'S DIABETES MEDICATION CHANGED IMMEDIATELY BEFORE OR SOMETIME AFTER THE AFOREMENTIONED SYMPTOMS AND THE EVENTS LEADING UP TO THE PATIENT'S REPORTED SYMPTOMS SUCH AS BLOOD GLUCOSE READINGS, DIABETES MEDICATION INTAKE, FOOD INTAKE, AND PHYSICAL ACTIVITIES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT SHE HAD SYMPTOM THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2841661

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening