BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3864441 · Received June 10, 2014

    Report

    Report Number
    2939301-2014-14046
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    June 6, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONETOUCH VERIO IQ METER WAS GIVING AN UNSPECIFIED ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2014, THE PATIENT OBTAINED AN UNSPECIFIED ERROR MESSAGE ON THE REPORTED METER; THE PATIENT WAS UNABLE TO PROVIDE THE SPECIFIC ERROR MESSAGE THAT OCCURRED. THE PATIENT WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT TOOK NO ACTIONS DUE TO THE METER ISSUE. AFTER THE USE OF THE METER, THE PATIENT EXPERIENCED THE SYMPTOM OF DIZZINESS. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT¿S SYMPTOM WAS NOT INDICATIVE OF SEVERE INJURY AND SHE DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE METER ISSUE WAS NOT RESOLVED THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340794 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3487702

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR