BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3840107 · Received May 30, 2014

    Report

    Report Number
    2939301-2014-12893
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 23, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - 7/9/2014. DEVICE EVALUATION.THE LAY USER/PATIENT¿S PRODUCTS HAVE BEEN RETURNED ON 6/10/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 7/4/2014 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE TESTED AND THE PRIMARY COMPLAINT WAS NOT 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

    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) 2014, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATE ERRATIC RESULTS. THE REPORTER OBTAINED BLOOD GLUCOSE VALUES OF 100 AND 75MG/DL A LIFESCAN METER WITHIN 20 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED FOR THE FOLLOWING REASON: BASED ON STATISTICAL METHODOLOGY, THE VARIATION BETWEEN THE TWO RESULTS EXCEEDS THE MAXIMUM ACCEPTABLE VALUE OF 20% VARIANCE BETWEEN READINGS TAKEN ON THE SAME METER WITHIN 20 MINUTES OF EACH OTHER. THE REPORTED RESULTS DID NOT MEET LIFESCAN'S ACCEPTABLE PRECISION CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318985 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1