BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO FLEX METER

    MDR report key: 4647186 · Received April 1, 2015

    Report

    Report Number
    2939301-2015-12950
    Event Type
    Malfunction
    Date Received
    April 1, 2015
    Report Date
    March 6, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1: (B)(6) 2015 - INFORMATION MISSING ON INITIAL 3500A: PMA/510(K) # SHOULD BE K150214.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ THE PATIENT¿S METER HAS BEEN RETURNED ON 3/19/2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 4/22/2015 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE TEST STRIPS ABLE TO MOVE WITHIN THE STRIP PORT, CAUSING INTERMITTENT ISSUE WITH ERROR 2 MESSAGE, AND WAS ALSO FOUND TO POWER DOWN IN USE WHILE TESTING. IN ADDITION, A SECONDARY ISSUE WAS NOTED WHEN THE METER WAS FOUND TO HAVE A CONTACT ISSUE WITH CONTACT BETWEEN SPC PIN 3 AND THE TEST STRIP IS LOST WHEN THE TEST STRIP IS SLIGHTLY MOVED TO THE RIGHT, RESULTING IN THE METER POWERING DOWN IN USE OR DISPLAYING ERROR 2 MESSAGE. 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

    THE METER ASSOCIATED WITH THIS COMPLAINT HAS BEEN RETURNED TO LIFESCAN; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED LIFESCAN (B)(4) ALLEGING THAT THE SUBJECT METER (ONETOUCH VERIO FLEX) HAD A METER CASING ISSUE - THE TEST STRIP WOULD MOVE WHEN BLOOD WAS APPLIED TO THE STRIP. 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
    213395 OT VERIO FLEX METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1