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

Catalog Number 04837738001

Device Problems Image Display Error/Artifact (1304); Device Difficult to Setup or Prepare (1487)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

The customer alleged there was an issue with the display of a coaguchek xs meter.The customer alleged measuring the following values on the meter: 2.8 inr on (b)(6) 2023.3.7 inr on (b)(6) 2023.The customer alleged that both values could not be read clearly on the display and that the issue had been happening for about one month.The customer alleged she had to tilt the meter back and forth in order to see the darkest segments on the results field of the display.A display check was performed and the results field and other parts of the display were dark and clear.When releasing the power button, the customer observed a test strip icon flashing on the display, but it was allegedly barely visible.The customer stated the batteries had been changed earlier and the battery compartment was clean and dry.

Manufacturer Narrative

The customer's meter was requested for investigation and a replacement product was sent to the customer.The investigation is ongoing.Medwatch field e3.Occupation - the occupation is patient/consumer.

Manufacturer Narrative

The returned meter was inspected.The circuit board of the meter was found to be contaminated and corroded by a penetrating liquid.The contamination also affected the conductive rubber contacts.Display segments failed in all areas.The contamination is due to a user error.The investigation could not identify a product problem.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17961628
• MDR Text Key: 326157011
• Report Number: 1823260-2023-03343
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• Combination Product (y/n): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

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: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1