BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4112543 · Received September 24, 2014

    Report

    Report Number
    2939301-2014-25287
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 19, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - 3/24/2015. DEVICE EVALUATION.THE LAY USER/PATIENT¿S TEST STRIPS AND METER HAVE BEEN RETURNED ON 12/17/2014 AND 11/4/2014, EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/8/2015 AND 12/2/2014 RESPECTIVELY WITH THE FOLLOWING FINDINGS:THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED.ERROR MESSAGE 4 OBSERVED IN THE ERROR LOG, BUT THE ERRORS WERE NOT REPRODUCED DURING THE INVESTIGATION. 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 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) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIOIQ METER DISPLAYED AN ¿ERROR 4¿ MESSAGE WHEN TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE METER MESSAGE OCCURRED ON AN UNSPECIFIED DATE IN JUNE 2014. IT IS UNKNOWN WHAT MEDICATION, IF ANY, THE PATIENT TAKES TO CONTROL HER DIABETES OR IF SHE TOOK ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED METER ISSUE. THE PATIENT REPORTED THAT SHE DEVELOPED A SYMPTOM OF ¿HIGH BLOOD PRESSURE¿ AN UNKNOWN TIME AFTER THE ERROR MESSAGE OCCURRED, HOWEVER IT IS UNKNOWN WHETHER SHE RECEIVED ANY TREATMENT. AT THE TIME OF TROUBLESHOOTING, IT WAS NOTED THAT THE CUSTOMER FOLLOWED THE CORRECT TESTING PROCESS AND THAT THE TEST STRIP COMPLETELY DREW IN THE SAMPLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE PRODUCT ISSUE CAUSED AND/OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT'S REPORTED SYMPTOM OF ¿HIGH BLOOD PRESSURE" DOES NOT MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY. THE PATIENT ALSO DENIED RECEIVING TREATMENT FROM A HEALTHCARE PROFESSIONAL AS A RESULT OF THE ALLEGED ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THE REPORTED GLUCOSE RESULTS EXCEEDS LFS¿S CRITERIA FOR PRECISION AND THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593141 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3658756

    Patients

    Seq Age Sex Outcome Treatment
    1