BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2072159 · Received April 28, 2011

    Report

    Report Number
    2939301-2011-03475
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER METER WAS READING INACCURATELY ERRATIC. 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 THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 7:45 (AM/PM NOT SPECIFIED). THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "389 AND 164 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 HER DIABETES REGIMEN, THE PATIENT CLAIMED SHE IS ON INSULIN. AT THE TIME THE ALLEGED ISSUE BEGAN, THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES REGIMEN. THE PATIENT REPORTED FEELING SWEATY, PANICKY, AND FAINT AFTER THE ALLEGED ISSUE BEGAN. IN SPITE OF HER SYMPTOMS, THE PATIENT DENIED SEEKING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT'S PROCESS FOR TESTING WAS CORRECT, THE RESULTS OBTAINED WERE FROM THE SAME APPROVED SAMPLE SITE, AND THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY. THE PATIENT DID NOT HAVE THE CONTROL SOLUTION TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. IT IS NOT KNOWN WHETHER THE PATIENT ASSOCIATED THE SYMPTOMS 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 ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3102567

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening