BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3233394 · Received July 18, 2013

    Report

    Report Number
    3008382007-2013-20250
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 9, 2013
    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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY COMPARED TO THE SAME METER. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED DURING (B)(6) 2013. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANGE HER DIABETES. THE PATIENT REPORTED ¿ALL DAY¿ ON THE DAY OF THE ALLEGED ISSUE SHE HAD MORE TO EAT OR DRINK ¿USING MANUFACTURED FOOD.¿ THE PATIENT REPORTED AT SOME POINT SHE FELT ¿SICK TO HER STOMACH.¿ THE PATIENT REPORTED ON (B)(6) 2013 AT 9PM SHE WAS GIVEN ADVICE FROM A HEALTHCARE PROFESSIONAL AND WAS ADVISED TO BE ¿ADMITTED TO EMERGENCY ROOM (ER).¿ THE PATIENT REPORTED ON (B)(6) 2013 AT 10PM A READING OF ¿140MG/DL¿ WAS OBTAINED BY AN EMERGENCY MEDICAL SERVICES (EMS) METER. IT IS UNCLEAR IF THE PATIENT WAS ADMITTED TO THE ER AND WAS TREATED FOR AN ACUTE COMPLICATION OF DIABETES. AT THE TIME OF TROUBLESHOOTING, THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE AND THEREFORE REQUIRED ASSISTANCE FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333116 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R