BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3071395 · Received April 22, 2013

    Report

    Report Number
    3008382007-2013-08559
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 1, 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
    CA, 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. SERIAL NUMBER INFORMATION WAS NOT PROVIDED. TEST STRIP LOT NUMBER NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT'S FIANCÉ CONTACTED LIFESCAN (LFS) ALLEGING THAT WHILE IN MEXICO THE ONETOUCH VERIO IQ METER WAS DISPLAYING A MESSAGE OF EXTREME HIGH GLUCOSE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). IT IS NOT KNOW WHEN THE ALLEGED METER ISSUE OCCURRED, THE PATIENT'S DIABETES MANAGEMENT IS NOT SPECIFIED AND IT IS NOT CLEAR WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE REPORTED METER ISSUE. IT IS NOT KNOWN IF THE PATIENT DEVELOPED ANY SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE AND IT IS NOT CLEAR IF THE PATIENT RECEIVED TREATMENT AFTER THE ALLEGED ISSUE OCCURRED. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE REPORTER DID NOT HAVE THE LFS PRODUCTS AVAILABLE AND THAT THE PATIENT HAD LEFT THE METER WITH HER SISTER IN (B)(6). A REPLACEMENT METER WAS SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THE PATIENT SUFFERED A SERIOUS INJURY OR RECEIVED MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED METER ISSUE. THIS COMPLAINT, HOWEVER, IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172391 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR