BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2880718 · Received December 20, 2012

    Report

    Report Number
    3008382007-2012-08643
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 5, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA2 METER WAS DISPLAYING INACCURATELY LOW RESULTS COMPARED TO A DOCTOR'S METER AND ANOTHER UNKNOWN METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO FOLLOW UP WITH THE PATIENT FOR ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER WAS UNSURE OF WHEN THE ISSUE FIRST STARTED, OR WHAT MEDICATIONS THE PATIENT USES TO MANAGE HIS DIABETES. THE REPORTER WAS UNSURE OF ANY BLOOD GLUCOSE READINGS OBTAINED. THE REPORTER WAS UNSURE IF THE PATIENT HAD MADE ANY CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE REPORTER STATED THE PATIENT DID NOT DEVELOP ANY SYMPTOMS HOWEVER REQUIRED GLUCOSE TREATMENT AT THE HOSPITAL. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE PATIENT'S TESTING PROCESS WAS FOUND TO BE CORRECT AND HE WAS USING AN APPROVED SAMPLE SITE. THE REPORTER DID NOT HAVE TEST STRIPS AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE REPORTER CLAIMS DUE TO THE ALLEGED ISSUE, THE PATIENT REQUIRED TREATMENT FROM A HEALTH CARE PROFESSIONAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R