BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4120341 · Received September 26, 2014

    Report

    Report Number
    2939301-2014-25429
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 18, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (03/24/2015).THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 2/12/2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 3/11/2015 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO HAVE RESULTS GREATER THAN +50% OF THE CONTROL SOLUTION WHEN TESTED WITH CONTROL SOLUTION. ADDITIONAL TESTS WERE PERFORMED ON THE TEST STRIP VIAL AND THE DESICCANT TO CHECK THE STRUCTURAL INTEGRITY AND FOR POSSIBLE MOISTURE ISSUE. THE STRUCTURAL INTEGRITY OF THE TEST STRIP VIAL WAS FOUND TO BE INTACT DURING A GROSS LEAK TEST. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO CONTAIN MORE MOISTURE THAN EXPECTED FROM NORMAL USE (AS PER PRODUCT LABELLING) AND FAILED TGA TESTING. 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 INACCURATE RESULT OF "311, 294 MG/DL" AS COMPARED TO THEIR NORMAL READINGS/FEELINGS ON (B)(6) 2014 AT 8:30 - 9PM. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE. THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM ON (B)(6) 2014 AT 10:00 OR 10:30PM. A BLOOD GLUCOSE TEST WAS PERFORMED BUT THE TEST RESULT WAS NOT PROVIDED. THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION. CONTROL SOLUTION TESTING WAS PERFORMED BUT DID NOT PASS. THIS COMPLAINT IS BEING REPORTED BECAUSE QUALITY CONTROL TESTING FAILED AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH 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
    601478 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3645276

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR