BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2943896 · Received February 5, 2013

    Report

    Report Number
    3008382007-2013-02301
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 29, 2013
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ((B)(4) 2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIP 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING HER ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN AT AN UNKNOWN DATE/TIME IN (B)(6) 2012. SHE TESTED AT AN UNKNOWN TIME AND REPORTED A BLOOD GLUCOSE READING OF "5.9 MMOL/L" WHICH SHE FELT WAS HIGH AS COMPARED TO HER FEELINGS. SHE CLAIMED JUST A FEW MINUTES PRIOR TO TESTING SHE WAS EXPERIENCING SYMPTOMS OF "HEADACHES AND FELT CONFUSED." THE PATIENT CLAIMED THAT SHE MANAGES HER DIABETES ORAL MEDICATIONS AND SHE DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED HIGH RESULT. THE PATIENT REPORTEDLY SELF TREATED HER SYMPTOMS WITH FOOD/DRINK. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE TEST STRIPS WERE IN GOOD CONDITION, A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED AND THERE IS NO EVIDENCE THE PATIENT ADMINISTERED INAPPROPRIATE SELF TREATMENT DUE TO THE ALLEGED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE RESULT OBTAINED WITH THE SUBJECT METER DID NOT CORRELATE WITH THE REPORTED SYMPTOMS AND FORM OF SELF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49318 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3385025

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR