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

Catalog Number 04625412003

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of missing segments in the test results field on a coaguchek xs meter with serial number (b)(4).While performing a display test on the meter, segments were missing from the results field that could potentially impact patient results.No incorrect or misinterpreted results were alleged.There was no allegation of an adverse event.The meter was requested for investigation.The meter was returned.The investigation determined the display was defective.The conductor tracks were interrupted.Many of the segments were displayed with a weak contrast.This issue was determined to be non-systematic.

Manufacturer Narrative

The customer's risk of interpreting a result incorrectly can be excluded since no meaningful digits were displayed.Instructions for performing a display check are covered in the operator's manual.With the display check prior to measurement, the customer is able to confirm that all results are visible on the display screen.

• Brand Name: COAGUCHEK XS KIT
• 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: 6709887
• MDR Text Key: 79899679
• Report Number: 1823260-2017-01457
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

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 Catalogue Number: 04625412003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 06/23/2017
• Supplement Dates FDA Received: 09/12/2017
• 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