BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 5305296 · Received December 17, 2015

    Report

    Report Number
    2939301-2015-54482
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Report Date
    December 7, 2015
    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
    PO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - DEVICE EVALUATION.THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS 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; HOWEVER A SECONDARY ISSUE OF AN ERROR 5 MESSAGE WAS OBSERVED WITH NO ASSIGNABLE CAUSE FOUND. 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) 2015, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THAT THE SUBJECT METER READ INACCURATELY ERRATIC. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "80, 142, 247 AND 337 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR PRECISION. 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
    835723 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3844534

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR