BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2011015 · Received March 8, 2011

    Report

    Report Number
    2939301-2011-01977
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2011:THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT AN UNKNOWN TIME. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF "216 AND 97 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. AS PART OF HIS DIABETES REGIMEN, THE PATIENT CLAIMED HE IS ON INSULIN. AS A RESULT OF THE ALLEGED INACCURATE RESULTS, THE PATIENT CLAIMED HE ADMINISTERED HIS DOSE OF INSULIN (TYPE AND DOSE UNKNOWN). THE PATIENT STATED HE BEGAN TO FEEL SHAKY AND LIGHT HEADED 30 MINUTES AFTER THE ALLEGED ISSUE OCCURRED; WHICH HE ASSOCIATED AS LOW BLOOD SUGAR SYMPTOMS. IN RESPONSE TO HIS SYMPTOMS, THE PATIENT INDICATED HE ATE SOME CANDY BARS. THE PATIENT STATED NO OTHER BLOOD GLUCOSE DEVICE WAS USED AT THE TIME OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE RESULTS OBTAINED WERE FROM THE SAME APPROVED SAMPLE SITE, THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY, AND THE PATIENT'S PROCESS FOR TESTING WAS CORRECT. THE PATIENT DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT OF "216 MG/DL", 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3079618

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| R