BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3071386 · Received April 22, 2013

    Report

    Report Number
    3008382007-2013-08557
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 11, 2013
    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
    CA
    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) (B)(4) ALLEGING THAT HER ONETOUCH VERIOIQ METER WOULD DISPLAY A "STRIP PROBLEM" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. PER THE COMMUNICATION RECEIVED, THE PATIENT WROTE "IF I DON'T GET THE BLOOD ON THE STRIPS EXACTLY THE RIGHT WAY, THE METER STATES CANNOT READ, STRIP PROBLEM". THE PATIENT MENTIONED SHE WAS DIAGNOSED WITH DIABETES IN (B)(6) 2012, BUT IS NOT KNOWN WHEN SHE FIRST BEGAN TO OBTAIN THE ALLEGED METER MESSAGE AND IF IT WAS ONLY APPEARING INTERMITTENTLY. IN HER COMMUNICATION TO LFS, SHE REPORTED THAT AT THE TIME SHE WAS COMPOSING HER EMAIL, THAT SHE ATTEMPTED TO TEST HER BLOOD GLUCOSE 5X IN LESS THAN 2 MINUTES AND OBTAINED THE METER MESSAGE. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF LANTUS INSULIN METFORMIN (ORAL MEDICATION). IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED METER ISSUE. PRIOR TO ATTEMPTING TO TEST HER BLOOD GLUCOSE ON (B)(6) 2013, THE PATIENT REPORTED DEVELOPING SYMPTOMS OF A "HEADACHE AND TENSION IN HER BACK" WHICH SHE REPORTED ASSOCIATING WITH A LOW GLUCOSE. THE PATIENT CLAIMED SHE TREATED HERSELF WITH FOOD TO BRING HER BLOOD GLUCOSE LEVELS UP. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT UNWILLING TO PERFORM BLOOD GLUCOSE TEST TO DETERMINE IF THE PATIENT WAS APPLYING THE SAMPLE CORRECTLY TO THE TEST STRIP. THE ALLEGED METER ISSUE REMAINED UNRESOLVED. 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 BECAUSE THE ALLEGED METER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172352 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3339968

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR