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

Catalog Number 03666794001

Device Problem No Display/Image (1183)

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

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer stated the results field of the coaguchek xs meter display seemed to be fading and he cannot always see the result.This may impact the interpretation of a result.While working with customer support, the customer states the meter would not power on.He changed the batteries and meter powered on but an error message was displayed indicating an error occurred during the internal diagnostic test.The meter was powered off and a display check was performed.The side and middle segments of the three "8s" were faded and some were missing.The customer stated the top and bottom segments of all the "8s" were dark and visible.There was no allegation of erroneous results or an adverse event.The meter was requested to be returned for investigation.

Manufacturer Narrative

The customer's meter was received for investigation.The circuit board was tested for damage or contamination and it was found the printed circuit board (pcb) was contaminated by liquid which has penetrated and/or corroded the solders contacts.Between the conductive rubber and the contacts of the circuit board, deposits could be seen which led to the failure of contacts.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.There was no malfunction of the device.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7430240
• MDR Text Key: 106267166
• Report Number: 1823260-2018-01164
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• 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: 04/23/2018
• Date Manufacturer Received: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1