BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2900475 · Received January 7, 2013

    Report

    Report Number
    3008382007-2013-00203
    Event Type
    Injury
    Date Received
    January 7, 2013
    Report Date
    December 26, 2012
    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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND THE METER HAS BEEN EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. EVALUATION OF THE TEST STRIPS HAS NOT YET STARTED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT'S SON CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. ON (B)(4) 2013, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. THE REPORTER/PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2012, AT APPROXIMATELY 10:19PM. SHE TESTED BACK TO BACK ON THE SUBJECT METER AND OBSERVED VALUES OF "77, 125 AND 104MG/DL" PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. THE PATIENT MANAGES HER DIABETES WITH 45U OF LEVEMIR INSULIN IN THE MORNING AND 25U OF HUMALOG INSULIN 3X PER DAY DURING MEALTIME AND DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. APPROXIMATELY 2 HOURS LATER, SHE REPORTEDLY DEVELOPED SYMPTOMS OF "SWEATING AND DISORIENTATION" AND SHE TREATED SELF WITH AN UNKNOWN FOOD/DRINK AT APPROXIMATELY 12:30AM ON (B)(6) 2012. NO OTHER DEVICE WAS USED FOR TESTING. 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. THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION AND STORED CORRECTLY. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. 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
    7627 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3340573

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R