BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2993760 · Received March 7, 2013

    Report

    Report Number
    3008382007-2013-04435
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ((B)(4) 2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIP HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND.

    Additional Manufacturer Narrative · 1

    THE METER/TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER HAS 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, THE PATIENT'S NIECE (REPORTER) CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE REPORTER CLAIMED THE ALLEGED ISSUE BEGAN ON THE SAME DAY SHE CONTACTED LFS AT APPROXIMATELY 2:52 PM. THE PATIENT REPORTEDLY TESTED BACK TO BACK ON THE SUBJECT DEVICE AND OBSERVED VALUES OF "114, 46, 57, 40, 117, 116, 44, 56 MG/DL" PERFORMED GREATER THAN 20 MINUTES OF EACH OTHER. DURING THE FOLLOW UP CALL WITH THE REPORTER, SHE ALSO ADDED AN ADDITIONAL READING OF "200 MG/DL" PERFORMED WITHIN THE SAME TIMEFRAME. THE PATIENT MANAGES HER DIABETES WITH REGULAR INSULIN BASED ON SLIDING SCALE, 10 U OF NPH IN THE MORNING, METFORMIN PILLS AND GLIPIZIDE PILLS 2 OF EACH, TWICE PER DAY. THE REPORTER CLAIMED THAT THE PATIENT INCREASED HER REGULAR INSULIN DOES BY AN UNKNOWN AMOUNT IN RESPONSE TO THE ALLEGED HIGH READING OF "200 MG/DL" AT 252 PM OF THAT SAME DAY. APPROXIMATELY 1 HOUR LATER, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "INCOHERENCE, SHAKING, SWEATING, AND NOT RESPONDING". THE REPORTER TESTED THE PATIENT'S BLOOD GLUCOSE USING A RELATIVE'S METER (ONETOUCH) AND OBSERVED READINGS OF "40, 42, 51 AND 67" BEFORE AND DURING TREATMENT. THE REPORTER ADMINISTERED SUGAR WATER AND AS SOON AS THE PATIENT WAS MORE RESPONSIVE SHE GAVE HER 2 GLUCOSE TABLETS. THE PATIENT REPORTEDLY FELT BETTER AFTER 1 HOUR AND WHEN SHE WAS RETESTED HER BLOOD GLUCOSE WAS "120 MG/DL" ON THE RELATIVE'S METER. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SAMPLES WERE OBTAINED FROM THE SAME APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS THE PATIENT OBTAINED INACCURATE READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98181 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3371087

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R