BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO FLEX METER

    MDR report key: 5499878 · Received March 15, 2016

    Report

    Report Number
    2939301-2016-12106
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Report Date
    February 22, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K150214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS AND THE INVESTIGATION CONCLUDED THAT INCORRECT TEST SPECIFICATIONS HAD BEEN USED DURING TESTING, WHICH HAVE BEEN ADDRESSED BY LIFESCAN'S QUALITY MANAGEMENT SYSTEM. THE METER HAS BEEN RE-EVALUATED FOLLOWING REVISED PROCEDURES USING THE CORRECT TEST SPECIFICATIONS, AND NO FAILURE RELATING TO INACCURACY WAS FOUND. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1: THE LAY USER/PATIENTS METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER FAILED TESTING. THE REPORTED ISSUE WAS CONFIRMED. A SECONDARY ISSUE WAS ALSO NOTED WHEN THE METER WAS FOUND TO BE READING BELOW RANGE. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT 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 REPORTER CONTACTED LIFESCAN (B)(4) ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE ON THREE OCCASIONS. THE REPORTER CLAIMED OBTAINING A BLOOD GLUCOSE READINGS OF "274, 249 AND 313MG/DL" RESPECTIVELY WITH THE SUBJECT METER AND "182, 182 AND 228MG/DL" RESPECTIVELY ON ANOTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. 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
    156175 OT VERIO FLEX METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR