BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3833327 · Received May 27, 2014

    Report

    Report Number
    2939301-2014-12566
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 26, 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
    FR
    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 IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONETOUCH VERIO IQ METER WAS GIVING INACCURATELY ERRATIC READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2014 AT 8:14 PM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 133 MG/DL AND 96 MG/DL ON THE REPORTED METER WITHIN 20 MINUTES. AT THAT TIME, THE PATIENT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE NEXT MORNING, THE PATIENT TOOK THE ACTION OF TAKING AN INCREASED DOSE OF LEVEMIR INSULIN, 7.0 UNITS INSTEAD OF 6.0; SHE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE PATIENT¿S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER AND CONTROL SOLUTION WERE REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT SUFFERED NO SYMPTOMS AND DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR PRECISION TESTING THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311559 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3628278

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR