BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 5409449 · Received February 4, 2016

    Report

    Report Number
    2939301-2016-05509
    Event Type
    Injury
    Date Received
    February 4, 2016
    Date of Event
    January 18, 2016
    Report Date
    January 28, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DEVICE EVALUATION: THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, 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 PRODUCT ISSUE BEGAN ON THE MORNING OF (B)(6) 2016 (TIME NOT PROVIDED). THE PATIENT STATED THAT HE OBTAINED A RESULT OF "160 MG/DL" USING THE SUBJECT METER COMPARED TO A RESULT OF "136 MG/DL" OBTAINED USING A CALIBRATED LAB DEVICE, BOTH RESULTS TAKEN WITHIN 10 MINUTES APART FROM EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 20%. THE PATIENT ALSO STATED THAT HE OBTAINED A RESULT OF "139 MG/DL" USING THE SUBJECT METER WHEN TESTED USING CONTROL SOLUTION. THE CONTROL SOLUTION RANGE WAS "102-138 MG/DL". 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 CLAIMED TO HAVE DEVELOPED THE SYMPTOMS OF "DIZZINESS, SWEATING AND CONFUSION" 20 MINUTES AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THE PATIENT STATED THAT HE SELF-TREATED WITH GLUCOSE TABLETS/GEL ON THE MORNING OF (B)(6) 2016 (TIME NOT PROVIDED) AFTER THE SYMPTOMS DEVELOPED. THE PATIENT STATED THAT HIS BLOOD GLUCOSE WAS TESTED USING ANOTHER DEVICE ON (B)(6) 2016 (TIME NOT PROVIDED) AND THE RESULT OBTAINED WAS "281 MG/DL".AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE, THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN, THE TEST STRIPS HAD NOT EXPIRED, BEEN OPEN FOR LONGER THAN THE DISCARD DATE OR STORED IMPROPERLY, THE PATIENT PERFORMED A WALK-THROUGH CONTROL SOLUTION TEST AND THE RESULT WAS IN RANGE, THE CORRECT CONTROL SOLUTION WAS BEING USED, THE CONTROL SOLUTION HAD NOT EXPIRED OR BEEN OPEN FOR LONGER THAN THE DISCARD DATE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING AND THE PATIENT WAS USING AN APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOM OF "SWEATING" AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THIS SYMPTOM DOES MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69770 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3860671

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R