BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2863670 · Received December 10, 2012

    Report

    Report Number
    3008382007-2012-07440
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 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
    NM, 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 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WAS DISPLAYING AN ERROR 5 METER MESSAGE. ACCORDING TO THE OT ULTRA2 METER OWNER'S MANUAL, AN ERROR 5 INDICATES THAT THE METER HAS DETECTED A PROBLEM WITH THE TEST STRIP. POSSIBLE CAUSES ARE TEST STRIP DAMAGE OR AN INCOMPLETELY FILLED CONFIRMATION WINDOW. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2012 AT 1 PM. THE PATIENT REPORTED USING ORAL MEDICATIONS INCLUDING METFORMIN 1000 MG ONCE A DAY TO MANAGE HER DIABETES. THE PATIENT REPORTED TAKING HER USUAL DOSE OF MEDICATION ON (B)(6) 2012, PRIOR TO 7:30 AM. THE PATIENT REPORTED 18 HOURS AFTER THE ALLEGED ISSUE FIRST STARTED, SHE DEVELOPED SYMPTOMS OF BEING "SHAKY AND NERVOUS". THE PATIENT REPORTED ON (B)(6) 2012 AFTER 7:30 AM, SHE SELF ADMINISTERED GLUCOSE TABLETS. THE PATIENT REPORTED ON (B)(6) 2012 AT 7:45 AM, SHE OBTAINED A READING OF "70 MG/DL" ON AN UNKNOWN METER. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED. THE CCA CONFIRMED THE PATIENT WAS USING THE CORRECT TESTING PROCESS AND THE TEST STRIPS WERE IN GOOD CONDITION. THE CCA CONFIRMED THE TEST STRIPS WOULD COMPLETELY DRAW IN THE SAMPLE BUT THE PATIENT DID NOT HAVE ANY TESTING SUPPLIES AT THE TIME OF THE CALL. 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, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT.

    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 3363087

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Life Threatening| R