BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3212854 · Received July 9, 2013

    Report

    Report Number
    3008382007-2013-19175
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS TO ADVISE AN INADVERTENT ERROR SUBMITTED ON THE INITIAL REPORT. EVALUATION OF THE SUBJECT METER AND TEST STRIPS WERE COMPLETED ON JULY 08, 2013 AND JULY 09, 2013, RESPECTIVELY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT¿S DAUGHTER (REPORTER) CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO THE EMERGENCY MEDICAL SERVICE¿S (EMS) METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE REPORTER BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2013 (AT 1:45 AM). THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING OF ¿72 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER); HOWEVER, THE PATIENT¿S TESTING FREQUENCY IS NOT KNOWN, IT IS NOT SPECIFIED WHAT THE PATIENT¿S NORMAL BLOOD GLUCOSE RANGE IS (WITH THE SUBJECT METER), AND OTHER THAN DIABETES, IT IS NOT CLEAR IF THE PATIENT SUFFERS FROM ANY OTHER HEALTH CONDITION(S). FOR REASONS UNCLEAR, THE EMS WAS CONTACTED AND AT 1:55 AM THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF ¿42 MG/DL¿ WITH THE EMS METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DO NOT EXCEED THE EXPECTED VALUE OF (B)(4). THE PATIENT¿S PREVIOUS BLOOD GLUCOSE READING PRIOR TO THE START OF THE ALLEGED ISSUE IS NOT KNOWN AND IT IS NOT CLEAR WHAT ACTION THE PATIENT TOOK IN RESPONSE TO HIS PREVIOUS BLOOD GLUCOSE RESULT. ACCORDING TO THE CSR¿S DOCUMENTATION, AT THE SAME TIME AFTER OBTAINING THE READING OF ¿42 MG/DL¿ WITH THE EMS¿S METER, THE PATIENT WAS ADMINISTERED IV GLUCOSE BY THE HEALTH CARE PROFESSIONAL. IT IS NOT KNOWN IF THE PATIENT RECEIVED ANY ADDITIONAL MEDICAL INTERVENTION. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER AND NOTED THAT THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER¿S MANUAL) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS RESPECTIVELY ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING WITH NO FAULTS FOUND; THE METER FUNCTIONED PROPERLY. THE TEST STRIPS ALSO PASSED TESTING WITH NO FAULTS FOUND. THE PRIMARY COMPLIANT WAS NOT CONFIRMED. ALTHOUGH IT IS UNKNOWN HOW THE PRODUCT MAY HAVE BEEN A FACTOR IN THE PATIENT¿S INJURY THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER ALLEGEDLY SUFFERED SYMPTOMS INDICATIVE OF A SERIOUS INJURY WHILE USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313468 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3388324

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention