BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO PLUS METER

    MDR report key: 5409419 · Received February 4, 2016

    Report

    Report Number
    2939301-2016-05478
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Report Date
    January 27, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP # 2 DEVICE EVALUATION. THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER FAILED TESTING. THE REPORTED ISSUE WAS 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 · 0

    THE PRODUCT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 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.

    Additional Manufacturer Narrative · 0

    THE LAY USER/PATIENT'S METER HAS BEEN FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE SUBJECT METER WAS FOUND TO MISCLASSIFY A BLOOD SAMPLE FOR 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. ON SEPTEMBER 21, 2020, LFS RECEIVED NOTIFICATION FROM THE FDA THAT THIS SUPPLEMENTAL WAS ON-HOLD AND HAD NOT BEEN SUCCESSFULLY RECEIVED BY THE AGENCY. LFS HAS BEEN ENGAGED WITH THE FDA SINCE SEPTEMBER 21, 2020, TO AGREE UPON REMEDIATION OF THE ON-HOLD ISSUE. ON MARCH 11, 2020, THE WORLD HEALTH ORGANIZATION (WHO) DECLARED THE COVID-19 OUTBREAK AS A GLOBAL PANDEMIC. IN LINE WITH FINAL GUIDANCE PUBLISHED BY THE FDA IN MAY, 2020, ENTITLED "POSTMARKETING ADVERSE EVENT REPORTING FOR MEDICAL PRODUCTS AND DIETARY SUPPLEMENTS DURING AN INFLUENZA PANDEMIC'; LFS HAS AGREED LATE REPORTING OF ALL ON-HOLD SUPPLEMENTALS. THIS SUBMISSION IS INCLUDED AS PART OF THAT AGREEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING BLOOD READING AS CONTROL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED 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
    68622 OT VERIO PRO PLUS METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3821706

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown