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

Catalog Number 03666794001

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of a display issue with coaguchek xs meter serial number (b)(4).The customer stated the display screen was very faint and there were segments missing from the top and bottom of the results field area.The customer saw numbers and "pictures" on the display but needed to move the unit around to see them.There was no allegation that an adverse event occurred.The device was requested for investigation.

Manufacturer Narrative

The device was returned.During the investigation a display test was performed and the circuit board was assessed for damage or contamination.The circuit board was contaminated by liquid which corroded the solder contacts.Parts of the display segments show a weak contrast.Deposits were found between the conductive rubber and the contacts of the printed circuit board.This leads to an interruption in the contacts.Medical risk is not likely due to this issue as display checks are addressed in product labeling and coaguchek users must receive training prior to using the device.The root cause of the issue is contamination of the contacts due to improper customer handling/maintenance.

• 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: 7148437
• MDR Text Key: 96051717
• Report Number: 1823260-2017-03133
• 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: 02/06/2018

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: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 02/06/2018
• 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