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

Model Number XS PST

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that the coaguchek xs meter (b)(4) did not show complete segments in the three large "8s" seen in the results display.All of the top segments were missing, as well as some missing on the bottom and right sides.There was no physical damage evident with the display screen or meter.The meter was no dropped prior to the display issue.There was no incorrectly displayed result received or reported.The customer's meter was requested for investigation.The meter was returned for investigation.Upon initial investigation, a display check was performed on the meter and missing segments in the result field could be confirmed.No adverse events were alleged.

Manufacturer Narrative

Further investigations of the meter determined that the segment failures on the display occurred due to a defective contact of the conductive rubber.This was caused by twisted installation of the display within the frame.After correcting the position of the display and conductive rubber, the display showed no error.The display issue was a non-systematic error.No medical risk is likely.

• 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: 7117098
• MDR Text Key: 95771627
• Report Number: 1823260-2017-02927
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: XS PST
• Device Catalogue Number: 03666794001
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2017
• 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