BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1081828 · Received July 23, 2008

    Report

    Report Number
    2939301-2008-01486
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 17, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE LFS PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE LFS PRODUCT DOES 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/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE LAY-USER/PATIENT ALLEGING THAT THE ONETOUCH ULTRA2 METER IS GIVING AN UNKNOWN ERROR MESSAGE. ON JULY 22, 2008, THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PATIENT TO CLARIFY INFORMATION OBTAINED DURING THE INITIAL PHONE. HOWEVER, THE PATIENT COULD NOT CLARIFY INFORMATION OBTAINED DURING THE INITIAL CALL. THE PATIENT TESTS HER BLOOD GLUCOSE MORE THAN 4 TIMES PER DAY AND TAKES A SET AMOUNT OF INSULIN PER DAY (NO ADJUSTMENT). THE PATIENT INDICATED THAT SHE OFTEN HAS SYMPTOMS OF SLURRED SPEECH AND FEELING SHAKY AND HAS HAD TO CALL THE PARAMEDICS ON SEVERAL OCCASIONS. UPON THE CALLBACK, THE PATIENT COULD NOT SPECIFY THE DATE AND TIME OF WHEN SHE RECEIVED MEDICAL INTERVENTION FROM THE EMT AND HOW THE REPORTED ISSUE MAY OR MAY NOT HAVE BEEN ATTRIBUTED TO THE INCIDENT. REPORTEDLY, SOMETIME IN THE PREVIOUS MONTH BETWEEN 12AM AND 1AM AFTER THE REPORTED ISSUE BEGAN, THE PATIENT CLAIMED SHE HAD SYMPTOMS OF "SLURRED SPEECH AND SHAKING." AS A RESULT ISSUE, THE PATIENT TOOK FOOD/BEVERAGE. THE PARAMEDICS WERE CALLED. UPON ARRIVAL, THE PATIENT OBTAINED AN UNKNOWN METER READING ON THE EMT METER AND DID NOT RECEIVE ANY DIABETES TREATMENT FROM EMERGENCY SERVICES. IT WOULD HAVE BEEN HELPFUL TO KNOW THE EVENTS LEADING TO THE PATIENT'S REPORTED SYMPTOMS AND MEDICAL INTERVENTION SUCH AS BLOOD GLUCOSE READINGS ON THE SUBJECT METER, DIABETES MEDICATION REGIMEN, FOOD INTAKE, AND PHYSICAL ACTIVITIES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF SEVERE 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2833970

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R