BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3191933 · Received June 27, 2013

    Report

    Report Number
    3008382007-2013-18558
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 5, 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
    KY, 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 THAT HER ONE TOUCH VERIO IQ METER WAS DISPLAYING AN ¿ERROR 1¿ MESSAGE. PER THE OWNER¿S BOOKLET, AN ERROR 1 APPEARS WHEN THERE IS AN ISSUE WITH THE METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER ALLEGED THE ISSUE FIRST OCCURRED ¿2 ½ MONTHS AGO¿. THE PATIENT MANAGES HER DIABETES WITH AN ORAL MEDICATION (GLIMEPIRIDE AND ACTOS) AND INSULIN (LANTUS , UNKNOWN DOSAGE). THE PATIENT DENIED TAKING ANY ACTION IN REGARDS TO HER NORMAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. ONE AND HALF MONTHS AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT REPORTED THAT SHE BEGAN TO DEVELOP ¿TINGLING IN FINGERS¿. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. 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 ALLEGED METER ISSUE REMAINED UNRESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292902 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR