MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME MONITOR

Model Number XS PLUS

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Patient Involvement (2645)

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).B)(4).Facility name - the full facility name was provided as "(b)(6)".

Event Description

On (b)(6) 2017, the customer complained stating that the touch screen of the coaguchek xs plus meter reacts in a cumbersome manner.The customer explained that the touch screen reacts sporadically and the system hangs up sometimes.The meter was requested for investigation and it was returned.Upon investigation, the functionality of the touch screen was tested; the touch screen was imprecise.When the day is selected on the screen, the month is set instead.There is a potential for confusion of results if the date is set incorrectly in the meter.

Manufacturer Narrative

A medical assessment determined the medical risk was unlikely in the event of incorrect date/time entry as the issue can be detected by the user and safety measures of the device are sufficient.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6380018
• MDR Text Key: 69158986
• Report Number: 1823260-2017-00470
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XS PLUS
• Device Catalogue Number: 04800842190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1