BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1893542 · Received November 8, 2010

    Report

    Report Number
    2939301-2010-09705
    Event Type
    Injury
    Date Received
    November 8, 2010
    Report Date
    October 21, 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 K021819.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRASMART METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELING/ NORMAL RESULT(S). THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON THE MORNING OF (B)(6), 2010. THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "120 MG/DL" WITH THE SUBJECT METER. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS); HOWEVER, AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DENIED TAKING ANY ACTION. APPROXIMATELY 20-30 MINUTES AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF SWEATING, DIZZINESS, AND WAS ALMOST UNCONSCIOUS. THE PATIENT, HOWEVER, DENIED SHE RECEIVED ANY TREATMENT AS A RESULT OF THE REPORTED METER ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER. 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. 3033084

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening