BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2032067 · Received March 28, 2011

    Report

    Report Number
    2939301-2011-02655
    Event Type
    Injury
    Date Received
    March 28, 2011
    Report Date
    March 9, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 K072543.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH SELECT METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELING/NORMAL RESULT(S). 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 HE OBTAINED ALLEGED HIGH READINGS OF "168 AND 157 MG/DL" WITH THE SUBJECT METER THAT BEGAN ON THE MORNING OF (B)(6) 2011. THE PATIENT CLAIMED HE MANAGES HIS DIABETES WITH INSULIN. AT THE TIME THE ALLEGED ISSUE BEGAN, THE PATIENT DENIED TAKING ANY ACTION REGARDING HIS DIABETES REGIMEN. ON AN UNSPECIFIED DATE/TIME, THE PATIENT REPORTEDLY BECAME SHAKY AFTER THE ALLEGED ISSUE BEGAN; HOWEVER IT IS NOT KNOWN WHETHER THIS SYMPTOM WAS ASSOCIATED AS HIGH OR LOW BLOOD SUGAR SYMPTOMS. IN SPITE OF THE REPORTED SYMPTOM, THE PATIENT DENIED SEEKING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY AND FOUND THE CODE ON THE METER WAS NOT SET CORRECTLY. ACCORDING TO THE CCA DOCUMENTATION, THE PATIENT WAS ABLE TO PERFORM A QUALITY CONTROL SOLUTION TEST THAT RESULTED WITHIN THE SPECIFIED RANGE ON THE VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. IT IS NOT KNOWN WHETHER THE PATIENT ASSOCIATED THE REPORTED SYMPTOM AS HIGH OR LOW BLOOD SUGAR SYMPTOMS. THEREFORE, 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 SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3067165

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening