BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2823034 · Received November 7, 2012

    Report

    Report Number
    3008382007-2012-06074
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 24, 2012
    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
    TX, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (2/11/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH VERIOIQ METER WAS DISPLAYING AN ERROR 2, ERROR 3, ERROR 4, AND AN ERROR 5 MESSAGE. ACCORDING TO THE OT VERIOIQ OWNER'S MANUAL, AN ERROR 2 COULD BE CAUSED EITHER BY A USED TEST STRIP OR A PROBLEM WITH THE METER. AN ERROR 3 INDICATES THAT THE BLOOD OR CONTROL SOLUTION SAMPLE WAS APPLIED PRIOR TO THE APPLY SAMPLE SYMBOL APPEARED ON THE DISPLAY. AN ERROR 4 INDICATES THAT: THERE WAS NOT ENOUGH BLOOD OR CONTROL SOLUTION WAS APPLIED OR MORE WAS ADDED AFTER THE METER BEGAN TO COUNT DOWN; THE TEST STRIP MAY HAVE BEEN DAMAGED OR MOVED DURING TESTING; THE SAMPLE WAS IMPROPERLY APPLIED; THERE MAY BE A PROBLEM WITH THE METER. AN ERROR 5 INDICATES THAT THE METER HAS DETECTED A PROBLEM WITH THE TEST STRIP. POSSIBLE CAUSES ARE TEST STRIP DAMAGE OR AN INCOMPLETELY FILLED CONFIRMATION WINDOW. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012 AT 5 OR 6PM, THE PATIENT ALLEGED THE ISSUES FIRST OCCURRED. THE PATIENT REPORTED USING ORAL MEDICATIONS WITH DIET AND EXERCISE TO MANAGE HIS DIABETES. THE PATIENT REPORTED ON (B)(6) 2012 AT 3 OR 4PM HE INCREASED HIS DOSE OF MEDICATION DUE TO THE ALLEGED ISSUE. HOWEVER THE PATIENT REPORTED 1 HOUR LATER HE DEVELOPED SYMPTOMS OF HAVING A HEADACHE, WAS NAUSEATED AND WAS DIZZY. THE PATIENT DENIED RECEIVING ANY MEDICAL INTERVENTION FOR AN ACUTE COMPLICATION OF DIABETES. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THIS WAS THE FIRST TIME THE METER HAD BEEN USED, AND THERE WAS NO MISUSE OF THE METER. THE PATIENT WAS USING THE CORRECT TEST STRIPS AND THE PATIENT'S TESTING PROCESS WAS CORRECT. THE CCA CONFIRMED THAT THE TEST STRIP COMPLETELY DREW IN THE SAMPLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S REPORTED SYMPTOMS DO NOT MEET LFS' CRITERIA FOR A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS OR TREATMENT SUGGESTIVE THAT AN ACUTE COMPLICATION OF DIABETES OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3311783

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR