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

Catalog Number	04837738001
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was a meter display issue with coaguchek xs meter, serial number (b)(6).Customer alleged the meter had a display malfunction that resulted in a misinterpretation of results.The results field of the meter is faded.The results field displayed a result of 5.4 inr on the day of the event.Customer did not believe this was the correct result due to the display issue.The customer did not report the result.
Additional Manufacturer Narrative
The meter was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.

• Brand Name: COAGUCHEK XS PST CARE KIT
• Common Device Name: 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22521917
• Report Number: 1823260-2025-02165
• Device Sequence Number: 8551265
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown