BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3198262 · Received July 1, 2013

    Report

    Report Number
    3008382007-2013-18733
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 7, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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) ALLEGING THE METER WAS HAVING AN UNUSUAL ISSUE, IT WAS DISPLAYING READINGS OF ¿GREATER THAN 800, 900 AND 1000 MG/DL.¿ THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT WAS UNABLE TO RECALL WHEN THE ALLEGED ISSUE FIRST STARTED. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HIS DIABETES AND TESTED 4 OR MORE TIMES A DAY. THE PATIENT REPORTED MAKING NO CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. HOWEVER THE PATIENT REPORTED ON AN UNKNOWN DATE AND TIME, HE WAS TREATED WITH NOVALIN R BY A HEALTHCARE PROFESSIONAL (HCP) IN THE EMERGENCY ROOM (ER). THE PATIENT REPORTED A BLOOD GLUCOSE READING WAS OBTAINED BY THE HCP HOWEVER THE PATIENT WAS UNABLE TO RECALL THE READING. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS UNABLE TO RESOLVE THE ALLEGED ISSUE WITH A WALK THROUGH. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS DUE TO THE ALLEGED ISSUE, THE PATIENT REQUIRED TREATMENT FROM AN HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298075 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3311774

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R