BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4120412 · Received September 26, 2014

    Report

    Report Number
    2939301-2014-25485
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 23, 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
    NC, US
    Reporter Occupation
    OTHER

    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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THE SUBJECT METER (ONETOUCH VERIOIQ) READ INACCURATELY HIGH IN COMPARISON TO THE PATIENT'S FEELINGS/NORMAL RESULTS. THE PATIENT REPORTED THAT THEY OBTAINED RESULTS OF "260 AND 267MG/DL" ON THE SUBJECT METER. DURING TROUBLESHOOTING THE CUSTOMER CARE ADVOCATE GOT THE PATIENT TO PERFORM A CONTROL SOLUTION TEST, AND THE RESULT WAS NOT IN RANGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601531 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3544428

    Patients

    Seq Age Sex Outcome Treatment
    1