BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4134017 · Received October 2, 2014

    Report

    Report Number
    2939301-2014-26130
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Report Date
    September 25, 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
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (11/17/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 10/2/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 11/5/2014 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 # 2- 12/18/2014. DEVICE EVALUATION. THE LAY USER/PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 10/28/2014, EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 11/26/2014 RESPECTIVELY 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 COMPROMISED DURING A GROSS LEAK TEST. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND NOT TO BE SATURATED BY MOISTURE AND THEREFORE PASSED 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 PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT HER ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT ALLEGED INACCURACY BEGAN ON (B)(6) 2014 AT 09:30 AM. THE PATIENT REPORTED OBTAINING AN INACCURATE HIGH BLOOD GLUCOSE RESULT OF ¿140 MG/DL¿ ON THE SUBJECT METER COMPARED TO ¿73 MG/DL¿ ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS FALLS OUTSIDE LIFESCAN¿S CRITERIA FOR ACCURACY. ON AN UNSPECIFIED TIME PRIOR TO THE PRODUCT ISSUE, THE PATIENT ALLEGED THAT SHE DEVELOPED SYMPTOMS OF ¿DIZZY, CONFUSED¿. THE PATIENT CURRENTLY MANAGES HER DIABETES WITH INSULIN PUMP THERAPY. SHE DENIED TAKING ANY ACTION IN RESPONSE TO HER REGULAR DIABETES MANAGEMENT ROUTINE AS A RESULT OF THIS ALLEGED PRODUCT ISSUE. ON (B)(6) 2014 AT 09:30 AM, THE PATIENT ALSO STATED THAT SHE SELF-TREATED WITH FOOD AND/OR DRINK. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE CORRECT UNIT OF MEASURE, SAMPLE SITE AND CORRECT TESTING PROCEDURE WAS USED AT THE TIME OF TESTING. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE METER ISSUE CAUSED AND/OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT FELT SYMPTOMATIC PRIOR TO THE START OF THE METER ISSUE. THEREFORE THE METER DID NOT CONTRIBUTE TO THE PATIENTS SYMPTOMS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE COMPARISON FELL OUT WITH LIFESCAN¿S ACCURACY CRITERIA AND THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616110 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3653538

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR