BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4032971 · Received August 25, 2014

    Report

    Report Number
    2939301-2014-21652
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Report Date
    August 16, 2014
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (11/04/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 9/25/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/23/2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL 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.

    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 # 1 ¿ (10/15/2014), THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 9/10/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/6/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO HAVE RESULTS ABOVE RANGE WHEN TESTED WITH CONTROL SOLUTION. ADDITIONAL TESTS WERE PERFORMED ON THE TEST STRIP VIAL AND THE DESICCANT TO CHECK THE STRUCTURAL INTEGRITY AND FOR POSSIBLE MOISTURE ISSUE. THE STRUCTURAL INTEGRITY OF THE TEST STRIP VIAL WAS FOUND TO BE INTACT DURING A GROSS LEAK TEST. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO BE SATURATED BY MOISTURE AND FAILED TGA TESTING. 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) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(6) ALLEGING THEIR ONE TOUCH VERIO IQ METER READ INACCURATELY HIGH WHEN COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2014. THE PATIENT CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿135MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH AN INSULIN PUMP. IT IS NOT KNOWN IF THE PATIENT ADMINISTERED A CORRECTION BOLUS IN RESPONSE TO THE ALLEGED INACCURATE HIGH RESULTS. THE PATIENT REPORTED DEVELOPING A SYMPTOM OF FEELING ¿DIZZY¿ HALF AN HOUR AFTER OBTAINING THE REPORTED READING. THE PATIENT REPORTED TREATING THIS SYMPTOM BY TAKING SOME SUGAR. AT THE TIME OF TROUBLESHOOTING THE CSR VERIFIED THAT UNIT OF MEASURE WAS SET CORRECTLY AND CONFIRMED THAT THE TEST STRIPS WERE STORED CORRECTLY (PER OWNER¿S BOOKLET RECOMMENDATION). THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S REPORTED SYMPTOM DOES NOT MEET LIFESCAN¿S CRITERIA FOR A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514556 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3649366

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR