BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 3160969 · Received June 11, 2013

    Report

    Report Number
    3008382007-2013-16384
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 23, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 SELECT METER WAS DISPLAYING INACCURATELY HIGH RESULTS COMPARED TO A HOSPITAL METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED BETWEEN (B)(6) 2013 TO (B)(6) 2013. THE PATIENT REPORTED OBTAINING A READING OF ¿75MG/DL¿ ON THE LFS METER COMPARED TO ¿50MG/DL¿ ON A HOSPITAL METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% OR <=30MG/DL WHEN OBTAINED WITHIN 30 MINUTES. THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED ABOUT 5 MINUTES AFTER THE ALLEGED ISSUE OCCURRED SHE DEVELOPED SYMPTOMS OF ¿SHAKES, SWEATY, HEADACHE, AND HEART POUNDING.¿ THE PATIENT REPORTED AFTER THE ALLEGED ISSUE OCCURRED, BETWEEN (B)(6) 2013 AT (B)(6) 2013 AT 2:30AM SHE WAS HOSPITALIZED AND A READING OF ¿50MG/DL¿ WAS OBTAINED ON A HOSPITAL METER AND WAS TREATED WITH IV GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE PATIENT WAS FOUND TO BE USING THE CORRECT TESTING STEPS AND APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES. THE PATIENT¿S TEST STRIPS AND TEST STRIPS VIAL WERE IN GOOD CONDITION. HOWEVER A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION 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 METER ISSUE, SHE WAS UNABLE TO TEST ON THE LFS METER ACCURATELY AND DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA REQUIRING TREATMENT FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263330 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3348133

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R