BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 6405292 · Received March 15, 2017

    Report

    Report Number
    3008382007-2017-12514
    Event Type
    Injury
    Date Received
    March 15, 2017
    Report Date
    March 9, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008372
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE REPORTED ISSUE WAS CONFIRMED. IN ADDITION, A SECONDARY ISSUE WAS OBSERVED; THE TEST STRIPS WERE FOUND TO HAVE RESULT BELOW RANGE WHEN TESTED WITH CONTROL SOLUTION. THE TEST STRIPS WERE FOUND TO HAVE RESULTS ABOVE RANGE WHEN TESTED WITH CONTROL SOLUTION. THE ADDITIONAL TESTS PERFORMED ON THE TEST STRIP VIAL AND THE DESICCANT WERE TO CHECK THE STRUCTURAL INTEGRITY AND FOR A POSSIBLE MOISTURE ISSUE. THE STRUCTURAL INTEGRITY OF THE TEST STRIP VIAL WAS FOUND TO BE INTACT DURING A GROSS LEAK TEST. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO CONTAIN LEVELS OF MOISTURE THAT REFLECT NORMAL USE (AS PER PRODUCT LABELING). 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) 2017, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER READ INACCURATELY HIGH IN COMPARISON TO HIS FEELINGS OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER DETAILED THAT ON (B)(6) 2017, AT 06:30AM, THE PATIENT OBTAINED RESULTS OF ¿240, 339 AND 430MG/DL¿ ON THE SUBJECT METER, WHICH THE PATIENT FELT WERE INACCURATELY HIGH. METER TO FEELINGS COMPARISONS DO NOT MEET LFS CRITERIA OF A VALID COMPARISON FOR ACCURACY. THE PATIENT MANAGES HIS DIABETES BY SELF-ADJUSTING HIS INSULIN DOSES AND INCREASED HIS INSULIN DOSE, BY TAKING ¿90 UNITS OF HUMALOG INSULIN¿ IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER STATED THAT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED THE PATIENT DEVELOPED SYMPTOMS OF ¿SWEAT, HEART COMPLICATIONS AND WEAKNESS¿ HOWEVER DENIED THAT HE RECEIVED ANY TREATMENT. DURING THE CALL THE CCA NOTED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE HOWEVER THE REPORTER DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A CONTROL TEST. THE PRODUCT WAS REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189009 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3933537 00353885008372

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening