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 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that the touch screen of the coaguchek xs plus meter responds incorrectly.When the day is selected upon input, the month is set instead.The meter was provided for investigation.Touch screen functionality was tested.It was determined that there was an x/y offset of touch on the "tft display".An imprecise touch screen was detected.The display issue may lead to a wrong input of a date or patient identifier.Patient results are displayed correctly, but may potentially be linked to a wrong patient identifier.The issue was determined to be a non systematic error.No adverse events occurred.

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: 6322914
• MDR Text Key: 67342728
• Report Number: 1823260-2017-00273
• 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

• 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: 02/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2017
• 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