BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1151409 · Received September 4, 2008

    Report

    Report Number
    2939301-2008-01998
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 8, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVAL, 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/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH ULTRA2 METER IS GIVING INACCURATE HIGH CONTROL SOLUTION RESULTS. THE PT INDICATED THE SUBJECT METER FIRST STARTED TO GIVE INACCURATE HIGH CONTROL SOLUTION RESULTS ON THE SAME DAY AT 2:46PM. SOMETIME AFTER THE REPORTED ISSUE BEGAN, THE PT REPORTEDLY HAD SYMPTOMS DESCRIBED AS "BLURRED VISION". THE PT DID NOT TAKE ANY ACTION IN REGARDS TO DIABETES TREATMENT AND DID NOT RECEIVE ANY MEDICAL INTERVENTION BECAUSE OF THE REPORTED ISSUE. IN ADDITION, THE PT DID NOT TEST ON ANY OTHER DEVICE AT THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PT'S TESTING FREQUENCY AND DIABETES MEDICATION REGIMEN, APPROXIMATELY HOW LONG AFTER THE INACCURATE HIGH CONTROL SOLUTION ISSUE BEGAN DID THE PT DEVELOP THIS SYMPTOM, THE DURATION OF THE REPORTED SYMPTOMS, WHAT TREATMENT THE PT RECEIVED TO ABATE THE SYMPTOMS, AND THE EVENT THAT LEAD UP TO THE AFOREMENTIONED SYMPTOMS SUCH AS LFS METER READINGS, DIABETES MEDICATION INTAKE, FOOD INTAKE, AND PHYSICIAN ACTIVITIES. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TEST STRIPS AND CONTROL SOLUTION ARE WITHIN THE DISCARD DATE AND IN GOOD CONDITION, THE CONTROL SOLUTION TEST WAS NOT WITHIN RANGE WHEN A CONTROL SOLUTION TEST WAS RUN WITH A NEW VIAL OF TEST STRIPS, THE METER IS CODED CORRECTLY, THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURED AREA WAS CLEANED APPROPRIATELY, AND THE CORRECT CONTROL SOLUTION WAS USED. HOWEVER, THE PT WAS UNWILLING/UNABLE TO VERIFY THAT THE CONTROL SOLUTION PASSED USING THE SUBJECT TEST STRIPS. THIS COMPLAINT IS BEING REPORTED DUE TO THE PT CLAIMED HE HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPERGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2823264

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Life Threatening