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

Catalog Number 03666794001

Device Problems Circuit Failure (1089); Display Difficult to Read (1181)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

The customer's meter was requested for investigation and replacement product was sent to the customer.Initial reporter occupation - the occupation is lay user/patient.

Event Description

It was reported that there was an issue with the display of coaguchek xs meter serial number (b)(4).When using the meter, the display appeared faded and difficult to read.A display check of the meter was performed and there were segments missing from the results field of the display.The issue persisted after changing the batteries.After the issue began, a result of 3.2 inr was measured from a patient.

Manufacturer Narrative

The meter was returned for investigation.The circuit board was tested for damage or contamination.The circuit board was found to be contaminated by a liquid that penetrated the device.The penetrating liquid affected the conductive rubber contacts of the circuit board, causing a short circuit.This would be caused by a user handling error.When turning on the meter, the display check shows missing segments.No plausible measurement results are displayed.

• 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: 12435398
• MDR Text Key: 273121150
• Report Number: 1823260-2021-02619
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• 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?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1