BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2240621 · Received September 9, 2011

    Report

    Report Number
    2939301-2011-08748
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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 K021819.

    Additional Manufacturer Narrative · 1

    (B)(6) 2012 SUPPLEMENTAL INFORMATION: PATIENT OUTCOME ATTRIBUTED TO ADVERSE EVENT WAS OMITTED IN ERROR ON THE 3500A.

    Additional Manufacturer Narrative · 1

    THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRASMART METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT STATED AT APPROXIMATELY 11AM JUST PRIOR TO CONTACTING LFS ON (B)(6) 2011 SHE TESTED HER BLOOD GLUCOSE AND RECEIVED RESULTS OF "131, 128 AND 117MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS WAS WITHIN THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. THE PATIENT INFORMED THE MSS THAT SHE MANAGES HER DIABETES WITH DIET ALONE AND TESTS HER BLOOD GLUCOSE ONCE PER DAY IN THE MORNING. THE PATIENT RECALLED THAT TOOK NO ACTION IN REGARDS TO HER NORMAL DIABETES MANAGEMENT ROUTINE WHEN SHE RECEIVED THE ALLEGED INACCURATE RESULTS. THE PATIENT CLAIMED THAT APPROXIMATELY WITHIN 10 MINUTES AFTER THE ALLEGED ISSUES OCCURRED, SHE BEGAN TO EXPERIENCE SYMPTOMS OF "NERVOUSNESS AND SHAKING." THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION TO TREAT HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT'S PROCESS FOR TESTING WAS CORRECT, THE SUBJECT METER'S UNIT OF MEASURE WAS CORRECT, AND THE SUBJECT TEST STRIPS WERE STORED CORRECTLY AND UNEXPIRED. A QUALITY CONTROL SOLUTION TEST WAS PERFORMED AND WAS WITHIN THE RANGE SPECIFIED ON THE TEST STRIP VIAL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. 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. 3151808

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening