BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT BASIC ENHANCED METER

    MDR report key: 2114776 · Received June 6, 2011

    Report

    Report Number
    2939301-2011-04586
    Event Type
    Injury
    Date Received
    June 6, 2011
    Report Date
    May 28, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 510 (K)# IS K023948. 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.

    Additional Manufacturer Narrative · 1

    FOR THE INITIAL REPORT INFORMATION WAS MISSING. SHOULD BE CHECKED MARKED AS LIFE THREATENING.

    Additional Manufacturer Narrative · 1

    (B)(4). SUPPLEMENTAL INFORMATION: PATIENT OUTCOME ATTRIBUTED TO ADVERSE EVENT WAS OMITTED IN ERROR ON THE 3500A

    Description of Event or Problem · 1

    THE LAY USER /PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING AN INSERT STRIP MESSAGE ON THEIR ONE TOUCH BASIC ENHANCED METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH THE METER BEGAN SOMETIME IN (B)(6) 2011. DUE TO THE ALLEGED ISSUE, THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE. APPROXIMATELY (B)(6) AFTER THE ALLEGED ISSUE BEGAN THE PATIENT FELT WEAK AND WAS SHAKY. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE TECHNIQUE OF APPLYING BLOOD ON THE TESTS TRIP WAS INCORRECT. THE PATIENT WAS USING EXPIRED TEST STRIPS. USING EXPIRED TEST STRIPS MAY LEAD TO FALSE BLOOD GLUCOSE READINGS. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED DUE TO THE INSERT STRIP MESSAGE, THE PATIENT WAS UNABLE TO TEST AND LATER DEVELOPED SYMPTOM SUGGESTIVE OF A SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening