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	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a display issue on a coaguchek xs meter.The customer stated that the meter display is faded and missing segments.They also alleged that they received a result of 1.2 inr, but they were not sure as the results were faded.The customer performed a display check and confirmed that there were missing segments in the number 8 on the display screen.The customer also changed the batteries on the meter and the screen was still faded.
Additional Manufacturer Narrative
The meter was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Sections d9 and h3 were updated.The meter was received for investigation.The meter display was inspected visually and a display check was performed.The display was clearly readable.The battery compartment was opened and corrosion due to liquid contamination was observed.Per product labeling, "do not let liquid accumulate near any opening.Make sure that no liquid enters the meter." the root cause of the event was found to be a user handling issue.No product problem was identified.

• 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: 22805872
• Report Number: 1823260-2025-02486
• Device Sequence Number: 8951323
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/03/2025

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: Health Professional
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WARFARIN.
• Patient Sex: Unknown