BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 4101214 · Received September 19, 2014

    Report

    Report Number
    2939301-2014-24807
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    September 9, 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 ¿ (10/20/2014), THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 10/10/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/12/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(6) ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN APPROXIMATELY 3 WEEKS PRIOR TO CONTACTING LFS FOR ASSISTANCE BUT COULD NOT SPECIFY EXACT DATE/TIME. THE PATIENT REPORTEDLY TESTED ON THE SUBJECT METER AND OBSERVED A READING THAT WAS ¿AROUND 100MG/DL¿ HIGHER THAN A RESULT FROM ANOTHER METER WHEN TESTING WAS COMPLETED WITHIN 30 MINUTES. THE PATIENT/REPORTER COULD NOT PROVIDE THE EXACT BLOOD GLUCOSE READINGS. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH BERLINSULIN INSULIN 3 X PER DAY, SELF-ADJUSTED BASED ON METER READINGS, ALONG WITH 30 UNITS OF LANTUS AT NIGHT AND TESTS UP TO 4 TIMES PER DAY. THE REPORTER CLAIMED THAT ON AN UNKNOWN DATE THE PATIENT TESTED HER BLOOD GLUCOSE JUST BEFORE GOING TO BED AT NIGHT AND OBTAINED A READING OF ¿480MG/DL.¿ THE PATIENT REPORTEDLY INJECTED AN UNKNOWN DOSE OF BERSULIN INSULIN BASED ON THE METER READING AND WENT TO SLEEP. AT APPROXIMATELY 3:10AM, THE PATIENT REPORTEDLY WOKE UP WITH SYMPTOMS OF ¿SHAKING, DIZZY, SWEATING AND CIRCULATION PROBLEMS¿ AND TESTED USING THE SUBJECT DEVICE AND OBSERVED A READING OF ¿49MG/DL.¿ THE PATIENT SELF-TREATED HER SYMPTOMS BY CONSUMING COOKIES, CHOCOLATE AND A GLASS OF COCOA AT AN UNKNOWN TIME. AT THE TIME OF TROUBLESHOOTING THE CSR CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SAMPLES WERE OBTAINED FROM THE SAME APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581621 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R