BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2863806 · Received December 10, 2012

    Report

    Report Number
    3008382007-2012-07488
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 28, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER WAS FOUND TO FUNCTION PROPERLY. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. THE RETAIN TEST STRIPS ALSO PASSED TESTING. THE PATIENT ALSO RETURNED AN EMPTY TEST STRIP VIAL; PA UNABLE TO PERFORM STRIP TESTING.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) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AROUND 8AM-9AM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "415, 362, 350 AND 250 MG/DL" WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN THROUGH PUMP THERAPY. BASED ON THE ALLEGED RESULTS, THE PATIENT ADMINISTERED SELF AN INCREASED DOSE OF INSULIN (0.8 UNITS -1 UNIT). A COUPLE HOURS AFTER, THE PATIENT FELT LOW BLOOD GLUCOSE SYMPTOMS OF SHAKY, DIZZY AND CONFUSED. THE PATIENT WAS GIVEN FOOD AND/ OR DRINK AS TREATMENT. THE PATIENT DENIED TESTING ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT WAS ALSO EDUCATED ABOUT PROPER TEST STRIP STORAGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, 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 ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3351808

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Life Threatening| R