BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1409935 · Received June 26, 2009

    Report

    Report Number
    2939301-2009-03922
    Event Type
    Injury
    Date Received
    June 26, 2009
    Report Date
    June 15, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 ONETOUCH ULTRA2 METER IS HAVING AN INACCURATE CONTROL LOW ISSUE. A NO RESPONSE LETTER WAS SENT TO THE PATIENT. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE REPORTED ISSUE BEGAN SOMETIME IN EARLY 2009. THE PATIENT INDICATED THAT THE CONTROL SOLUTION RESULT OF 69 MG/DL WAS OUTSIDE THE CONTROL SOLUTION RANGE OF "113-151 MG/DL." AT AN UNSPECIFIED DATE AND TIME AFTER THE REPORTED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS DESCRIBED AS "EXCESSIVE THIRST AND MILD HEADACHES." IT IS NOT KNOWN WHAT BLOOD GLUCOSE READING THE PATIENT OBTAINED ON THE SUBJECT METER AT THE TIME OF CONCERN. DURING FEBRUARY OR EARLY MARCH, THE PATIENT'S LANTUS INSULIN REGIMEN WAS INCREASED BY 5 UNITS. AS A RESULT OF THE REPORTED ISSUE, THE PATIENT TOOK 25 UNITS OF LANTUS. THE PATIENT DID NOT TEST ON ANY OTHER DEVICES. 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 MEDICAL INTERVENTION SUCH AS BLOOD GLUCOSE READINGS, DIABETES MEDICATION INTAKE, FOOD INTAKE, AND PHYSICAL ACTIVITIES. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TEST STRIPS ARE WITHIN THE DISCARD DATE AND IN GOOD CONDITION, THE CONTROL SOLUTION TEST WAS NOT WITHIN RANGE WHEN A CONTROL SOLUTION TEST WAS RUN, AND THE METER IS CODED CORRECTLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPERGLYCEMIA AFTER THE INACCURATE CONTROL LOW 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 2926718

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening