BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3852611 · Received June 6, 2014

    Report

    Report Number
    2939301-2014-13492
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    May 26, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/01/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 8/7/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/20/2014 WITH THE FOLLOWING FINDINGS:NO ERROR MESSAGE IS OBSERVED IN THE ERROR LOG, AND ERROR WAS 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

    FOLLOW-UP # 2 ¿ (09/16/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 8/29/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/3/2014 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHERE THE TEST STRIPS WERE FOUND TO HAVE SHELF LIFE EXCEEDED. 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 LAY USER/PATIENT¿S WIFE (REPORTER) CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THE ONETOUCH VERIOIQ METER DISPLAYED AN UNKNOWN ERROR MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2014 (AT 5AM). ACCORDING TO THE CSR¿S DOCUMENTATION, THE PATIENT FELT SICK JUST BEFORE THE ALLEGED ISSUE BEGAN AND FOLLOWING THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY ADMINISTERED AN EXTRA DOSE OF METFORMIN. THE PATIENT DID NOT TEST WITH ANOTHER DEVICE AFTER THE PRODUCT ISSUE OCCURRED. THE PATIENT WAS UNABLE/UNWILLING WITH PERFORM A RETEST; THEREFORE, THE ALLEGED METER ISSUE REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO EVIDENCE THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY BECAUSE THE PATIENT REPORTEDLY FELT SICK PRIOR TO THE ALLEGED PRODUCT ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332731 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3444745

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR