BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3840104 · Received May 30, 2014

    Report

    Report Number
    2939301-2014-12890
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 23, 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
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH VERIO IQ METER HAS A DATA PORT ISSUE (DATA CABLE WILL NOT FIT INTO THE PORT). THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE PATIENT ENCOUNTERED THE ONSET OF THE DATA PORT ISSUE ON (B)(6) 2014 AT 2 PM. THE PATIENT FELT WARM 1 HOUR AFTER THE DATA PORT ISSUE BEGAN. THERE WAS NO REPORT OF ANY REQUIRED MEDICAL TREATMENT AS A RESULT OF THE ISSUE. THE DATA PORT ISSUE WAS NOT RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED DUE TO THE UNRESOLVED DATA PORT ISSUE. THERE WAS NO EVIDENCE OF A SERIOUS INJURY ASSOCIATED WITH THE DATA PORT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318984 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3615921

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR