BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO2 METER

    MDR report key: 6220999 · Received January 4, 2017

    Report

    Report Number
    3008382007-2017-00411
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    December 16, 2016
    Report Date
    December 18, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008730
    PMA / PMN Number
    K131363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE LAY USER/PATIENT¿S MOTHER CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) AFTER REVIEWING THE CALL RECORDING. DURING THE CALL, THE REPORTER ADVISED THAT THE SUBJECT METER HAD BEEN READING INACCURATELY HIGH FOR SOME TIME PRIOR THE PATIENT DEVELOPING A ¿SEIZURE¿ AT 1 P.M., ON (B)(6) 2016. THE REPORTER DID NOT PROVIDE THE ALLEGED INACCURATE RESULTS. THE REPORTER CLAIMED THAT THE PATIENT MANAGES HIS DIABETES WITH INSULIN AND IT IS NOT KNOWN WHAT CHANGES, IF ANY, HE MADE TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. IT IS ALSO NOT KNOWN WHAT TREATMENT, IF ANY, THE PATIENT RECEIVED IN RESPONSE TO THIS SYMPTOM. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, THAT AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE READINGS AND THAT THE CORRECT TESTING METHOD WAS BEING FOLLOWED. THE CSR CONFIRMED THAT THE TEST STRIP VIAL WAS INTACT, THAT THE TEST STRIPS HAD BEEN STORED PROPERLY, WERE NOT OPEN BEYOND THEIR DISCARD DATE AND HAD NOT EXPIRED. THE CSR ALSO WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND THE RESULT OBTAINED FELL WITHIN THE EXPECTED RANGE OF 102-138 MG/DL. THE SUBJECT PRODUCTS WERE REQUESTED BACK FOR INVESTIGATION AND REPLACEMENTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5606 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 00353885008730

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Life Threatening