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

Catalog Number	03666794001
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	Coagulation Disorder (1779)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On visual inspection by the patient, no debris was found in the battery compartment.It was confirmed that the batteries were installed properly.The terminals were cleaned, but the issue persisted.The batteries were then replaced, but the meter would not power on.The customer's meter was returned for investigation.The meter powered on without difficulty using fresh batteries.The customer's returned meter was tested with retention strips and retention controls.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.7 inr; qc 2: 2.7 inr; qc 3: 2.7 inr.The obtained qc values were in the allowed range of the used combination strip lot: qc lot.All measurements were without error messages.No corrosion, contamination, or damage was observed.The customer's allegation of a power issue could not be confirmed.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.E3: occupation was patient/consumer.
Event or Problem Description
There was an allegation of an adverse event for one patient while using the coaguchek xs meter.The patient alleged the meter was not available for use due to a power issue one week prior to hospitalization.The patient was reportedly admitted to the hospital on (b)(6) 2025 due to heart failure, a collapsed lung, high inr levels, and renal failure.The patient alleged the result from the hospital lab upon admission was 5.5 inr.The patient alleged that warfarin was stopped when admitted.The patient reported she did not receive vitamin k but was unsure of which medications were given.It was reported that 2.5 liters of fluid were removed from her right lung, which had collapsed.The patient alleged there was blood in the fluid that was removed.The patient was reportedly in the hospital for five days.The patient¿s current condition was reported to be stable.The patient¿s therapeutic range was provided as 2.0-3.0 inr, and the patient tested once a month.The patient follows a diabetic diet, a warfarin diet, a low-sodium diet, and a heart-healthy diet.

• Brand Name: COAGUCHEK ® XS SYSTEM
• 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: 22979857
• Report Number: 1823260-2025-02764
• Device Sequence Number: 9027941
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 09/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/05/2025
• 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: ASPIRIN 81 MG; CALCIUM SUPPLEMENT; HYDRALAZINE; METFORMIN; PRILOSEC; SIMVASTATIN; VITAMIN D3; WARFARIN
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 54 KG