BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2335775 · Received November 14, 2011

    Report

    Report Number
    2939301-2011-11013
    Event Type
    Injury
    Date Received
    November 14, 2011
    Report Date
    November 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. THE 510(K) # IS K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT/LAY-USER CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE WAS EXPERIENCING AN INACCURATE HIGH ISSUE AND AN INACCURATE LOW ISSUE WITH HER ONE TOUCH ULTRASMART METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON (B)(6) 2011, AT 6:30 AM AND CONTINUED THRU (B)(6) 2011. IN THE SPAN OF THOSE DAYS, SHE OBTAINED GLUCOSE RESULTS OF '164, 173, 232, 174, 185, 265, 202 AND 246 MG/DL' ON THE SUBJECT METER, WHICH SHE FELT WERE INACCURATE HIGH COMPARED TO HER FEELINGS/NORMAL VALUES. IN THE SAME DATE RANGE, SHE ALSO OBTAINED GLUCOSE RESULTS OF '56, 28, 79, 74, 67, 62, 76 AND 80 MG/DL', WHICH SHE FELT WERE INACCURATE LOW COMPARED TO HER FEELINGS/NORMAL VALUES. THE EXACT TIME OF WHEN EACH RESULT WAS OBTAINED IS UNKNOWN. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH NOVOLOG INSULIN (SELF ADJUSTER) AND SINCE THE ISSUE STARTED ON (B)(6) THRU (B)(6) SHE MANAGED WITH MORE FOOD AND/OR DRINK. DURING THE EVENTS WHEN SHE GOT THE INACCURATE HIGH RESULTS, SHE DENIED DEVELOPING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE, BUT FOR THE EVENTS WHEN SHE GOT THE INACCURATE LOW RESULTS, AT THE 'SAME DAY AND TIME' SHE CLAIMED FEELING 'SHAKY, COLD CHILLS, DISORIENTED AND DROWSY'. IN RESPONSE TO THE ALLEGED ISSUES, BETWEEN (B)(6) THRU (B)(6) 2011 SHE REPORTEDLY SELF TREATED WITH NOVOLOG INSULIN BETWEEN 1-7U. THERE WAS NO OTHER DEVICE AVAILABLE AT THE TIME OF THE CONCERN. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE METER SET TO THE CORRECT UNIT OF MEASURE. 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 ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3069077

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R