OMNI

Additional Manufacturer Narrative

THE CUSTOMER SENT IN PRINTER MODULE WITH SERIAL NUMBER (B)(4) FOR INVESTIGATION. NO DAMAGE WAS IDENTIFIED DURING THE VISUAL INSPECTION. A FEW HEATING PIXELS ON THE HEATING COMB OF THE PRINTER MODULE WERE IDENTIFIED AS BEING DEFECTIVE. THE SPECIFIC ROOT CAUSE OF THIS DEFECT COULD NOT BE IDENTIFIED. THE PRINTOUTS SHOWED THAT THE FIRST DECIMAL PLACE OR THE LAST DIGIT OF PARAMETER RESULTS ONLY PARTIALLY READABLE OR NOT READABLE, HOWEVER THE MEASUREMENT RESULTS CAN BE CHECKED AND COMPARED VIA INSTRUMENT SCREEN AND MEASUREMENT DATABASE, WHERE THE RESULTS DISPLAYED CORRECTLY.

Description of Event or Problem

THE CUSTOMER COMPLAINED THAT THE INSTRUMENT PRINTED INCOMPLETE RESULTS WHEN RUNNING REPORTS. THE CUSTOMER REPEATED THE PRINTING AND THE RESULTS STILL APPEARED INCOMPLETE. THE CUSTOMER OBTAINED THE RESULTS FROM THE INSTRUMENT SCREEN AND MANUALLY COMPLETED THE REPORTS. THE ISSUE OCCURRED SEVERAL TIMES BEFORE THE PRINTER MODULE WAS REPLACED. IT IS UNCLEAR HOW MANY TIMES THIS OCCURRED. ONE PATIENT'S GLUCOSE RESULT WAS AFFECTED. IT IS UNCLEAR IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENT OCCURRED. THE PRINTER MODULE WAS REPLACED BY THE FIELD SERVICE ENGINEER ON 04/09/2015. THE AFFECTED PRINTER MODULE SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).