MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK VANTUS USA; PROTHROMBIN TIME MONITOR

Catalog Number	07729952160
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Dizziness (2194)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not submitted for investigation.The investigation did not identify a product problem.
Additional Manufacturer Narrative
The coaguchek xs pt test 6 strip lot number is 78789521, with an expiration date of 30-nov-2025.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and the results have passed the internal inspection.The investigation is ongoing.
Event or Problem Description
We received an allegation of a questionable inr result for one patient tested with the coaguchek vantus usa meter compared to an unknown laboratory method.The laboratory result at 4:13 pm was 2.97 inr.The meter result at 5:56 pm was 4.2 inr.The patient's therapeutic range is 2.5 to 3.5 inr.

• Brand Name: COAGUCHEK VANTUS USA
• 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: 23061942
• Report Number: 1823260-2025-02901
• Device Sequence Number: 21284359
• Product Code: GJS
• UDI-Device Identifier: 00365702700499
• UDI-Public: 00365702700499
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K170960
• 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): 10/16/2025

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: 07729952160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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