BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3171410 · Received June 15, 2013

    Report

    Report Number
    3008382007-2013-17313
    Event Type
    Injury
    Date Received
    June 15, 2013
    Report Date
    May 28, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 ULTRAMINI METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO A DOCTOR¿S METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED ON (B)(6) 2013 AT 5:39AM SHE OBTAINED A READING OF ¿57MG/DL¿ ON THE LFS METER. THE PATIENT REPORTED USING A COMBINATION OF MEDICATIONS INCLUDING INSULIN, METFORMIN AND ACTOS (UNKNOWN DOSES). THE PATIENT REPORTED ON (B)(6) 2013 AT 5:30AM SHE HAD SOMETHING MORE TO EAT OR DRINK. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED ON (B)(6) 2013 AT 9AM SHE WAS SEEN IN A DOCTOR¿S OFFICE AND A READING OF ¿30MG/DL¿ WAS OBTAINED ON A FREESTYLE METER AND SHE WAS GIVEN A ¿GLUCAGON INJECTION¿ BY A HEALTHCARE PROFESSIONAL. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND AN APPROVED SAMPLE SITE FOR TESTING. HOWEVER, THE METER VS. ANOTHER METER COMPARISON WAS INVALID SINCE THE READINGS WERE TAKEN MORE THAN 30 MINUTES APART. 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 REQUIRED ASSISTANCE FROM A HEALTHCARE PROFESSIONAL FOR SEVERE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272688 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3438936

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R