BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4141452 · Received October 4, 2014

    Report

    Report Number
    2939301-2014-26413
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Report Date
    September 15, 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
    NY, 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) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH VERIO IQ METER CONTINUED TO DISPLAY AN ¿ERROR 4¿ MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER ISSUE BEGAN ON (B)(6) 2014 AROUND 8:00AM. THE PATIENT REPORTED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE. IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ERROR MESSAGE APPEARING: HOWEVER, SHE REPORTED DEVELOPING SYMPTOM OF ¿LIGHTHEADEDNESS¿ HALF TO ONE HOUR LATER. AT THE ONSET OF HER SYMPTOM, THE PATIENT CLAIMED SHE TOOK MORE FOOD AND DRINK. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CSR CONFIRMED THE CORRECT TESTING PROCESS WAS BEING FOLLOWED BUT NOTED THE PATIENT DID NOT HAVE TESTING SUPPLIES AVAILABLE TO TEST THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, 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 ALLEGED METER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621567 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3516955

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR