BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3233990 · Received July 18, 2013

    Report

    Report Number
    3008382007-2013-20278
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 10, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE PATIENT ALLEGING THE PATIENT¿S ONETOUCH VERIOIQ METER WAS PROMPTING AN UNKNOWN ERROR MESSAGE WHEN SHE WAS ATTEMPTING TO TEST HER BLOOD GLUCOSE AND WAS DISPLAYING INACCURATELY HIGH READING COMPARED TO HIS FEELINGS OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 AT 8 AM. THE REPORTER STATED THE PATIENT OBTAINED A ¿HI¿ MESSAGE ON THE METER . THE PATIENT REPORTED USING A COMBINATION OF MEDICATIONS INCLUDING NOVOLOG ON A SLIDING SCALE, NOVOLOG 70/30 AND LEVEMIR 8 UNITS IN THE MORNING. THE REPORTER STATED ON (B)(6) 2013 AT 8 AM THE PATIENT INCREASED HIS USUAL DOSE OF NOVOLOG TO INCLUDE 5 ADDITIONAL UNITS. THE REPORTER STATED 20-30 MINUTES LATER THE PATIENT DEVELOPED SYMPTOMS OF FEELING ¿HOT, SHAKY, SWEATY AND NOT FEELING GOOD.¿ THE REPORTER STATED ON (B)(6) 2013 AT 12 PM THE PATIENT WAS SEEN IN A DOCTOR¿S OFFICE AND A BLOOD GLUCOSE READING OF ¿30 MG/DL¿ WAS OBTAINED AND HE WAS GIVEN GLUCOSE TABLETS AS TREATMENT. THE REPORTER STATED THE PATIENT WAS ALSO ADVISED NOT TO USE EXPIRED TEST STRIPS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND HIS TEST STRIPS WERE IN GOOD CONDITION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS DUE TO THE ALLEGED ISSUE THE PATIENT INCREASED HER USUAL DOSE OF MEDICATION, DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333178 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3388177

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening| R