BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2383884 · Received December 21, 2011

    Report

    Report Number
    3008382007-2011-01076
    Event Type
    Injury
    Date Received
    December 21, 2011
    Report Date
    December 14, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(4) 2012 THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE EVALUATED AND ER4 WAS OBSERVED WITH CONTROL SOLUTION TESTING. THE RETAIN TEST STRIPS WERE ORDERED AND PASSED ALL TESTING. ON (B)(4) 2012 THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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. THE 510(K) # IS K110637.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE PATIENT/LAY-USER CONTACTED LIFESCAN (LFS) CANADA ALLEGING THAT HE WAS EXPERIENCING AN "ER4" ISSUE WITH HIS NEW ONE TOUCH VERIO IQ METER. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE DURING A FOLLOW UP PHONE CALL TO THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON AN UNSPECIFIED "3 DAYS" PRIOR TO CONTACTING LFS, WHEN HE FIRST GOT IT OUT OF THE BOX. HE STATED THAT HE WAS NEVER ABLE TO GET IT WORK, AND NEVER GOT AN ACTIONABLE RESULT FROM THE METER. THE PATIENT REPORTED TESTING 5X/DAY AND MANAGES HIS DIABETES WITH 500 MG OF METFORMIN, 90U OF LEVEMIR (NO ADJUSTMENTS) AND 1 MG OF GLIPIZIDE. THE PATIENT CLAIMED "3-4 HOURS LATER" AFTER THE ALLEGED ISSUE STARTED, HE FELT "THIRSTY AND SLEEPY", WHICH HE ASSOCIATED TO A HYPERGLYCEMIC STATE. HE DENIED RECEIVING ANY FORM OF MEDICAL TREATMENT IN RESPONSE TO HIS SYMPTOMS AND CONFIRMED THAT THE SYMPTOMS EVENTUALLY STOPPED. THE PATIENT STATED HE HAS NO USUAL TREATMENT ROUTINE RELATED TO THIS TYPE OF INCIDENT. IT WAS NOTED THAT THE PATIENT WAS USING ANOTHER METER BEFORE AND AFTER THE ALLEGED ISSUE OCCURRED. HE WAS UNABLE TO RECALL WHEN HE USED IT AND THE RESULTS OBTAINED ON THE OTHER METER AT THE TIME OF THE CONCERN. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT TEST STRIPS, AND AN APPROPRIATE TESTING TECHNIQUE. IT WAS ALSO NOTED THAT THE METER WAS IN USE FOR THE VERY FIRST TIME AND IT WAS AN OUT OF BOX FAILURE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    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 3205421

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening