BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3183547 · Received June 22, 2013

    Report

    Report Number
    3008382007-2013-17986
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Report Date
    May 24, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONE TOUCH VERIO IQ METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN ¿SINCE LAST DECEMBER 2012¿. AT AN UNSPECIFIED DATE/TIME THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE RESULTS OF ¿48, 71 MG/DL¿ WITH THE SUBJECT METER PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT ALSO REPORTED OBTAINING BLOOD GLUCOSE RESULTS OF ¿60, 120, 40, 70, 80 MG/DL¿ WITH THE SUBJECT METER PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE BETWEEN THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 20%. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET, AND EXERCISE. SHE DENIED TAKING ANY ACTION IN REGARDS TO HER NORMAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. THE CCA NOTED THAT THE PATIENT WAS UNABLE TO CONFIRM IF SHE DEVELOPED SYMPTOMS AS A RESULT OF THE ALLEGED INACCURACY. THE PATIENT REPORTED SCHEDULING 4 DOCTOR OFFICE VISITS (DATES OF VISITS ARE UNKNOWN). DURING ONE OF THE DOCTOR OFFICE VISITS, THE PATIENT CONFIRMED HER BLOOD GLUCOSE WAS TESTED WITH A DOCTOR/CLINIC METER AND RECEIVED A RESULT OF 120 MG/DL. THE PATIENT WAS ADVISED BY HER HCP TO ¿CONTINUE TO MONITOR BLOOD GLUCOSE AND EXERCISE¿. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AT THE TIME TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE SUBJECT METER DID NOT MEET LFS¿ PRECISION CRITERIA AND THE ALLEGED METER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284268 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR