BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3110356 · Received May 13, 2013

    Report

    Report Number
    3008382007-2013-11339
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED BUT NOT YET EVALUATED BY LIFESCAN PRODUCT ANALYSIS. LFS WILL EVALUATE IT AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING, NO FAULTS WERE FOUND, AND THE METER FUNCTIONED PROPERLY. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. THE TEST STRIPS PASSED TESTING WITH NO FAULTS FOUND.IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. 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 ALLEGED ISSUE BEGAN ON (B)(6) 2013, ABOUT 130AM. IT WAS REPORTED THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "98 MG/DL" WITH THE SUBJECT METER AND "38 MG/DL" ON ANOTHER 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 MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL MANAGEMENT ROUTINE. THE REPORTER DENIED THE PATIENT DEVELOPED SYMPTOMS AT THAT TIME. ON THE EVENING BEFORE THE START OF THE ALLEGED ISSUE, ON (B)(6) 2013, AT 11PM, THE REPORTER ALLEGED THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS ADMINISTERED INTRAVENOUS (IV) GLUCOSE. BLOOD GLUCOSE RESULTS OR SYMPTOMS WERE NOT SPECIFIED AT THAT TIME. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT WITH ANOTHER METER SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210886 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3442995

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening