BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3212268 · Received July 9, 2013

    Report

    Report Number
    3008382007-2013-19171
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 30, 2013
    Report Date
    July 1, 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
    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 HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY LOW COMPARED TO AN EMERGENCY MEDICAL SERVICES (EMS) METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS WELL AS ADDITIONAL INFORMATION. THE PATIENT REPORTED THE ALLEGED ISSUE OCCURRED ON (B)(6) 2013 AT 10 PM. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HIS DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED 1.5 HOURS AFTER THE ALLEGED ISSUE OCCURRED HE DEVELOPED SYMPTOMS OF ¿CONVULSIONS, PROFUSE SWEATING.¿ THE PATIENT REPORTED ON (B)(6) 2013 AT 11:30 PM HE WAS SEEN BY EMS AND A READING OF ¿33 MG/DL¿ WAS OBTAINED AND THE PATIENT WAS GIVEN IV GLUCOSE BY EMS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT. THE CCA NOTED THAT THE PATIENT¿S TEST STRIPS AND TEST STRIPS VIAL WERE IN GOOD CONDITION. THE PATIENT WAS FOUND TO BE USING THE CORRECT TESTING STEPS AND AN APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, A SEVERELY LOW READING WAS OBTAINED ON AN EMS METER AND HE WAS TREATED BY EMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312576 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