BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4120397 · Received September 26, 2014

    Report

    Report Number
    2939301-2014-25460
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 19, 2014
    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
    VA, US
    Reporter Occupation
    PATIENT

    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 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY HIGH IN COMPARISON TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS THE PATIENT WAS UNAVAILABLE FOR FOLLOW-UP WHEN MEDICAL SURVEILLANCE TRIED TO MAKE CONTACT. THE PATIENT CLAIMED THAT ON AN UNSPECIFIED DATE IN (B)(6) 2014, HE OBTAINED A READING OF ¿184MG/DL¿ ON THE SUBJECT DEVICE WHICH HE FELT WAS INACCURATELY HIGH COMPARED WITH A READING OF ¿124MG/DL¿ OBTAINED ON AN UNSPECIFIED DEVICE, WHEN PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THE PATIENT CLAIMED THAT IMMEDIATELY BEFORE THE ALLEGEDLY HIGH RESULT HE DEVELOPED SYMPTOMS OF FEELING ¿SWEATY¿¿ AND ¿DIZZY¿. THE PATIENT DETAILED THAT HE MANAGES HIS DIABETES WITH A COMBINATION OF ORAL MEDICATION, DIET AND EXERCISE AND REPORTED THAT AS A RESULT OF THE ALLEGEDLY INACCURATE RESULT HE HAD BEEN TAKING AN INCREASED DOSE OF HIS USUAL MEDICATION (GLIPIZIDE 1MG), FROM (B)(6) 2014 UNTIL PRESENT. THE PATIENT CLAIMED THAT (B)(6) 2014 HE VISITED A DOCTOR¿S OFFICE WHERE HE HAD A BLOOD GLUCOSE TEST PERFORMED ON A CLINIC METER, WHICH GAVE A RESULT OF LESS THAN, OR EQUAL TO, 40MG/DL. THE CCA NOTED THAT THE UNITS OF MEASURE WERE SET CORRECTLY AT THE TIME OF TESTING AND THAT THE CORRECT TESTING STEPS AND SAMPLE SITE HAD BEEN USED. THE CCA DETAILED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A CONTROL SOLUTION TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SIGNS OF SEVERE HYPOGLYCEMIA, AFTER TAKING INAPPROPRIATE ACTION IN RESPONSE TO THE ALLEGEDLY INACCURATE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601751 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3650581

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R