BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4810138 · Received June 2, 2015

    Report

    Report Number
    2939301-2015-22175
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Report Date
    May 20, 2015
    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
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING THAT HIS ONETOUCH VERIO IQ METER READ INACCURATELY HIGH. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED INACCURACY BEGAN EARLY MARCH AT APPROXIMATELY 5:35AM (DATE NOT PROVIDED). THE PATIENT STATED THAT HE OBTAINED A RESULT OF "218 MG/DL" USING THE SUBJECT METER COMPARED TO A RESULT OF "126 MG/DL" USING ANOTHER DEVICE, BOTH READINGS TAKEN WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT MANAGES HIS DIABETES WITH FIXED-DOSE INSULIN. THE PATIENT CONFIRMED THAT HE DID NOT MAKE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT STATED THAT NO SYMPTOMS DEVELOPED. THE PATIENT STATED THAT HE HAD MADE SEVERAL VISITS TO HIS ENDOCRINOLOGIST'S OFFICE AND HAD ALSO RECEIVED TELEPHONE ADVICE FROM HIS ENDOCRINOLOGIST. HE WAS ADVISED TO DISPOSE OF THE SUBJECT METER AND TO INSTEAD USE ANOTHER METER. THE PATIENT STATED THAT HIS BLOOD GLUCOSE HAD BEEN TESTED USING A DOCTOR/CLINIC DEVICE (DATE/TIME NOT PROVIDED) BUT HE COULD NOT PROVIDE THE RESULT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE TEST STRIPS HAD NOT EXPIRED OR BEEN OPEN FOR LONGER THAN THE DISCARD DATE, THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN, THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM A WALK-THROUGH TEST, THE TEST STRIPS WERE NOT IDENTIFIED AS COUNTERFEIT/SUSPECT, THE PATIENT WAS USING AN APPROVED SAMPLE SITE, THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE AND THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THERE IS NO EVIDENCE THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS AND THERE WAS NO TREATMENT FOR A SEVERE HIGH OR LOW BLOOD GLUCOSE EXCURSION. THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355102 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3653538

    Patients

    Seq Age Sex Outcome Treatment
    1