BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PROFILE METER

    MDR report key: 1911100 · Received November 30, 2010

    Report

    Report Number
    2939301-2010-10368
    Event Type
    Injury
    Date Received
    November 30, 2010
    Report Date
    November 8, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    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. 510(K) # IS K023948.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PROFILE METER WAS DISPLAYING THE "NOT OK" MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT FOR A FOLLOW UP CALL ON (B)(6) 2010 AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT HER TESTING FREQUENCY IS 3 TIMES A DAY BEFORE EACH MEAL AND MANAGES HER DIABETES WITH INSULIN. THE PATIENT STATED SHE ADMINISTERS 2 DIFFERENT TYPES OF INSULINS INCLUDING HUMALOG (26 UNITS IN THE MORNING AND 36 UNITS BEFORE SUPPERTIME) AND HUMULIN (70 UNITS IN THE MORNING AND 36 UNITS BEFORE BEDTIME. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN AT LEAST 6 MONTHS AGO PRIOR TO CONTACTING LFS. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT DENIED MAKING ANY CHANGES TO HER DIABETES MANAGEMENT ROUTINE. THE PATIENT CLAIMED 4 HOURS AFTER THE START OF THE ALLEGED ISSUE, SHE WAS FEELING SWEATY, SHAKY, AND LEGS WERE WEAK AND UNABLE TO WALK STRAIGHT; WHICH SHE ASSOCIATED AS LOW BLOOD SUGAR SYMPTOMS. IN RESPONSE TO THE SYMPTOMS, THE PATIENT CONFIRMED SHE DRANK ORANGE JUICE AND ATE BREAD AND PEANUT BUTTER. THE PATIENT CLAIMED AFTER THE SELF TREATMENT SHE WAS FEELING BETTER. THE PATIENT DENIED TESTING ON ANOTHER DEVICE AT THE TIME OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THE PATIENT'S TESTING STEPS WERE CORRECT; HOWEVER WAS NOT ABLE TO DETERMINE WHETHER THE TEST STRIPS WERE IN GOOD CONDITION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PROFILE METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R