BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1968159 · Received January 21, 2011

    Report

    Report Number
    2939301-2011-00726
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 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 MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS ON (B)(6) 2011 AND (B)(6) 2011. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2011 AT 6:25AM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "255, 224, 216, 214, 193, 234, 210, AND 253 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS IS LESS THAN THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE PATIENT CLAIMED HE MANAGES HIS DIABETES WITH PILLS AND DIET/EXERCISE. IT IS UNCLEAR IN THE DOCUMENTATION IF THE PATIENT MADE ANY CHANGES TO HIS DIABETES REGIMEN AT THE TIME OF THE ALLEGED ISSUE. ABOUT 4 HOURS AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT STATED HE WAS FEELING NAUSEAS AND SHAKY. BY 11:15AM THAT DAY, THE PATIENT INDICATED HE CONTINUED TO TAKE HIS USUAL DOSE OF MEDICATION AND DRANK 4 OUNCES OF ORANGE JUICE. IT IS NOT KNOWN IF THE PATIENT TESTED ON ANOTHER BLOOD GLUCOSE DEVICE AT THE TIME OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE RESULT FROM THE SUBJECT METER AND THE CORRECT UNIT OF MEASURE WAS SET CORRECTLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED INACCURATE ERRATIC READINGS ON THE SUBJECT METER AND 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3018758

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R