BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3070614 · Received April 22, 2013

    Report

    Report Number
    3008382007-2013-08548
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT APPROXIMATELY 9:15 AM. HE TESTED ON THE SUBJECT METER DURING AND OBSERVED A VALUE OF "286 MG/DL" AND THEN TESTED ON A CONTOUR METER WITHIN 30 MINUTES AND OBTAINED A READING OF "129 MG/DL". BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4). THE PATIENT MANAGES HIS DIABETES WITH AN UNKNOWN TYPE/DOSE OF SELF ADJUSTING INSULIN AND CONTINUED WITH HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS AND REPORTED THAT HE WENT TO SEE HIS DOCTOR AT 9:15 AM THE FOLLOWING DAY AND WAS GIVEN NOVOLOG INSULIN (80 UNITS 2X PER DAY). NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SAMPLES WERE OBTAINED FROM THE SAME APPROVED SAMPLE SITE. THE TEST STRIPS WERE UNEXPIRED AND IN GOOD CONDITION. A CONTROL TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS AND FORM OF TREATMENT PROVIDED BY THE HCP WAS CONSISTENT WITH THE ALLEGED HIGH METER READINGS. HOWEVER, THE COMPLAINT IS BEING REPORTED BECAUSE THE METER DID NOT MEET LFS' CRITERIA FOR ACCURACY WHEN COMPARED TO ANOTHER METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173157 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3322011

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR