BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO2 METER

    MDR report key: 6071818 · Received November 2, 2016

    Report

    Report Number
    3008382007-2016-56394
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 22, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2016 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIO2 METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED WHEN THE MEDICAL SURVEILLANCE SPECIALIST REQUESTED THE CSR FOLLOW-UP WITH THE PATIENT. THE PATIENT STATED THAT THE ALLEGED METER ISSUE BEGAN ON (B)(6) 2016 AROUND 5:30PM WHEN SHE OBTAINED A READING OF 104 OR 105MG/DL USING THE SUBJECT METER. THE PATIENT CLAIMED EXPERIENCING SYMPTOMS OF SHAKY, WEAK, HEADACHE, FEELING HEAVY, TINGLING FINGERS AND HEATED APPROXIMATELY 5-10 MINUTES PRIOR TO OBTAINING THIS MEASUREMENT. DURING FOLLOW-UP, THE PATIENT STATED THAT HER PREVIOUS BLOOD GLUCOSE MEASUREMENT PRIOR TO THE ONSET OF THESE SYMPTOMS WAS AROUND 12 NOON THAT DAY WITH A RESULT WITHIN HER NORMAL RANGE APPROXIMATELY 100MG/DL. THE PATIENT STATED THAT SHE DOES NOT TAKE ANY MEDICATIONS TO MANAGE HER DIABETES AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. THE PATIENT REPORTEDLY VISITED THE EMERGENCY ROOM (ER) ON (B)(6) 2016 AT APPROXIMATELY 8:14PM WHERE HER BLOOD GLUCOSE WAS MEASURED USING AN ER METER WITH A RESULT OF 65MG/DL COMPARED TO A READING OF 132MG/DL USING THE SUBJECT DEVICE, BOTH READINGS WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THESE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THE PATIENT REPORTEDLY RECEIVED HCP TREATMENT OF FOOD AND/OR DRINK AT 9PM IN RESPONSE TO THE REPORTED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR DETERMINED THAT THE METER WAS SET WITH THE CORRECT UNIT OF MEASURE, AN APPROVED SAMPLE SITE WAS BEING USED, THE TEST STRIPS WERE STORED CORRECTLY AND WITHIN EXPIRY AND THE PATIENT'S TESTING PROCEDURE WAS CORRECT. THE CSR NOTED THAT THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. RETURN OF THE SUBJECT DEVICE FOR INVESTIGATION WAS REQUESTED AND REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. ALTHOUGH THE PATIENT STATED THAT THEY EXPERIENCED SIGNS AND/OR SYMPTOMS THAT MEET LFS' CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT BEFORE THE ALLEGED PRODUCT ISSUE BEGAN, THIS COMPLAINT IS BEING REPORTED AS IT CANNOT BE SAID WITH ABSOLUTE CERTAINTY THAT THE ALLEGED INACCURATE SUBJECT METER RESULTS DID NOT AFFECT TREATMENT OPTIONS PRIOR TO THE ONSET OF THESE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723801 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4069280

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R