BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3140466 · Received May 31, 2013

    Report

    Report Number
    3008382007-2013-14039
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 6, 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
    VA, 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. DATE OF EVENT: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF ¿GREATER THAN 600 MG/DL¿ ON THE REPORTED METER, WHICH SHE CLAIMED WAS INACCURATELY HIGH COMPARED TO HER EXPECTED RESULTS. AT THAT TIME, THE PATIENT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PATIENT REPORTED THAT SHE WENT TO THE EMERGENCY ROOM, WHERE SHE RECEIVED TREATMENT. THE PATIENT WAS UNABLE TO SPECIFY THE TYPE OF TREATMENT RECEIVED. TROUBLESHOOTING REVEALED THE PATIENT¿S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE PATIENT ALLEGEDLY RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT AFTER OBTAINING AN ELEVATED BLOOD GLUCOSE READING ON THE REPORTED METER, THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242000 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3238638

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening| R