BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3024343 · Received March 27, 2013

    Report

    Report Number
    3008382007-2013-06358
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 9, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ((B)(4) 2013)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(6) 2013 AND (B)(6) 2013 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE REPORTED COMPLAINT WAS OBSERVED ON THE ERROR LOG, HOWEVER, PA WAS UNABLE TO REPRODUCE FAILURE IN TEST. THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, ANOTHER FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY COMPARED TO THE SAME METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED, THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) /2013 AT 4:54AM. THE PATIENT REPORTED OBTAINING READINGS OF "148, 79, 216 AND 241 MG/DL" ON THE SAME METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE READINGS EXCEEDS THE EXPECTED RESULT OF <=20% OR <=20MG/DL OBTAINED WITHIN 20 MINUTES OF EACH OTHER. IT IS UNCLEAR IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED RIGHT AFTER THE ALLEGED ISSUE OCCURRED SHE DEVELOPED SYMPTOMS OF FEELING "HOT, SWEATY AND UNCONSCIOUS." THE PATIENT REPORTED ON (B)(6) 2013 AT 4:54AM SHE HAD SOMETHING TO EAT OR DRINK IN RESPONSE TO HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE REPORTER STATED THE PATIENT WAS USING AN APPROVED SAMPLE SITE FOR TESTING AND HER TESTING STEPS WERE CORRECT. THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE PATIENT¿S TEST STRIP VIAL AND TEST STRIPS WERE IN GOOD CONDITION. A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT SINCE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND REQUIRED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125295 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3408171

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R