BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4123913 · Received September 27, 2014

    Report

    Report Number
    2939301-2014-25623
    Event Type
    Malfunction
    Date Received
    September 27, 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
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    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 HE OBTAINED ERRATIC RESULTS WHEN TESTING WITH HIS ONETOUCH VERIO IQ METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT ALLEGED THAT ON (B)(6) 2014 AT 06:30 PM, HE OBTAINED INACCURATE READINGS OF ¿141MG/DL¿, ¿210MG/DL¿ AND ¿375MG/DL¿ WHEN TESTING HIS BLOOD GLUCOSE USING THE SUBJECT METER. THE TESTS WERE REPORTEDLY PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT DETAILED THAT HIS DIABETES IS USUALLY MANAGED BY SELF-ADJUSTING HIS INSULIN DOSES AND DENIED TAKING ANY ACTION REGARDING HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGEDLY INACCURATE RESULTS. THE PATIENT REPORTED THAT 15 TO 20 MINUTES AFTER THE METER ISSUE OCCURRED HE ALLEGEDLY DEVELOPED SYMPTOMS OF ¿STAGGERING¿ AND ¿DIZZINESS¿, HOWEVER DENIED RECEIVING ANY TREATMENT. THE CCA NOTED THAT AT THE TIME OF THE INACCURACY AN APPROVED SAMPLE SITE HAD BEEN USED AND THAT THE METER WAS SET TO THE CORRECT UNITS OF MEASURE. THE CCA WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND THE RESULT WAS NOT IN RANGE. 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 SYMPTOMS OF ¿STAGGERING¿ AND ¿DIZZINESS¿ DO NOT MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY. THE PATIENT ALSO DENIED RECEIVING TREATMENT 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
    603845 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3544419

    Patients

    Seq Age Sex Outcome Treatment
    1