BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4791400 · Received May 22, 2015

    Report

    Report Number
    2939301-2015-20717
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    April 30, 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
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 3 - 24/09/2015: SUPPLEMENTAL SENT TO CORRECT INFORMATION PREVIOUSLY OMITTED FROM FOLLOW UP 1, THE EVALUATION CODES WERE NOT INCLUDED IN THE SUBMISSION. THIS SUPPLEMENTAL IS ALSO BEING SENT TO CORRECT INFORMATION PREVIOUSLY OMITTED FROM THE ADDITIONAL MFR NARRATIVE IN FOLLOW UP 2; ADDITIONAL TESTS WERE PERFORMED ON THE TEST STRIP VIAL AND THE DESICCANT TO CHECK THE STRUCTURAL INTEGRITY AND FOR POSSIBLE MOISTURE ISSUE. THE STRUCTURAL INTEGRITY OF THE TEST STRIP VIAL WAS FOUND NOT TO BE COMPROMISED DURING A GROSS LEAK TEST. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO CONTAIN LEVELS OF MOISTURE THAT REFLECT NORMAL USE. 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

    FOLLOW-UP # 1 CORRECTION - SUPPLEMENTAL SENT TO CORRECT INFORMATION PREVIOUSLY SENT. ALERT DATE SHOULD HAVE STATED (B)(6) 2015.

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1: THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO HAVE RESULTS ABOVE RANGE WHEN TESTED WITH 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.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING MULTIPLE INACCURACIES ON THE SUBJECT METER. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF 206MG/DL WITH THE SUBJECT METER AND ALLEGED THAT THIS READING WAS INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL RESULTS. THE REPORTER ALSO CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF 206MG/DL WITH THE SUBJECT METER AND 137MG/DL ON ANOTHER ONETOUCH VERIOIQ METER PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE REPORTER ALSO CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF 150MG/DL WITH THE SUBJECT METER AND 137MG/DL ON AN ACCUCHECK METER PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. DURING TROUBLESHOOTING THE SUBJECT METER FAILED A CONTROL SOLUTION TEST. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334282 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3763877

    Patients

    Seq Age Sex Outcome Treatment
    1