BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 4120379 · Received September 26, 2014

    Report

    Report Number
    2939301-2014-25472
    Event Type
    Injury
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (12/15/2014).THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 12/3/2014 AND 12/15/2014, RESPECTIVELY, AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/5/2014 AND 12/15/2014, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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. 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 ¿ (12/27/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 12/15/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/17/2014 WITH THE FOLLOWING FINDINGS: 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 BE SATURATED BY MOISTURE AND FAILED TGA TESTING. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON 12/12/2014 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/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 REPORTER CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THE PATIENT¿S ONE TOUCH VERIO IQ METER WAS READING INACCURATELY HIGH WHEN COMPARED TO ANOTHER METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. IT IS UNKNOWN WHEN THE ALLEGED PRODUCT ISSUE FIRST BEGAN. THE PATIENT MANAGES THEIR DIABETES WITH AN INSULIN PUMP. THE REPORTED STATED THAT THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF ¿288MG/DL¿ ON THE SUBJECT METER AND ADJUSTED THEIR INSULIN IN RESPONSE TO THIS READING. 15 MINUTES LATER THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF ¿258MG/DL¿ ON THE SUBJECT METER AND ¿81MG/DL¿ ON A ROCHE METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THE REPORTER STATED THAT AROUND 60 MINUTES AFTER THESE TESTS THE PATIENT DEVELOPED A SYMPTOM OF ¿SWEATING¿. THE PATIENT TESTED THEIR BLOOD GLUCOSE ON THE ROCHE METER AND REPORTED A READING OF ¿40MG/DL¿. THE PATIENT WAS REPORTEDLY TREATED BY FAMILY MEMBER WITH SUGAR. THE CSR WAS NOT ABLE TO TROUBLESHOOT WITH THE PATIENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED A SERIOUS SYMPTOM ASSOCIATED WITH HYPOGLYCEMIA AFTER OBTAINING THE ALLEGED INACCURATE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601800 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R