BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SS ENHANCED METER

    MDR report key: 2047821 · Received April 11, 2011

    Report

    Report Number
    2939301-2011-02984
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 K022724.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH SURESTEP METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN BETWEEN 9:00PM AND 9:30PM 3 WEEKS AGO PRIOR TO CONTACTING LFS. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "300 MG/DL" WITH THE SUBJECT METER AND "172 MG/DL" ON ANOTHER METER (UNKNOWN BRAND METER), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT CLAIMED HE MANAGES HIS DIABETES WITH 3 DIFFERENT TYPES OF ORAL MEDICATIONS AND INSULIN. DESPITE THE ALLEGED ISSUE, THE PATIENT INDICATED HE ADMINISTERED 55 UNIT OF LANTUS INSULIN AS USUAL ON (B)(6) 2011 BETWEEN 10:00PM AND 10:30PM. THE FOLLOWING DAY BETWEEN 5:30AM AND 6:00AM, THE PATIENT REPORTED HE WAS FEELING WEAK AND SWEATY. IN RESPONSE TO HIS SYMPTOMS, THE PATIENT STATED HE WAS TREATED WITH FOOD AND/OR DRINK BY ANOTHER HEALTH CARE PROFESSIONAL (HCP). THE PATIENT INDICATED NO OTHER BLOOD GLUCOSE DEVICE WAS USED AT THE TIME THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE RESULT FROM THE SUBJECT METER, THE UNIT OF MEASURE WAS SET CORRECTLY ON THE METER, AND THE PATIENT'S TESTING PROCEDURE WAS CORRECT. HOWEVER, THE CCA WAS NOT ABLE TO RESOLVE THE ALLEGED ISSUE SINCE THE PATIENT DID NOT HAVE THE TEST STRIPS AND THE CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R