MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST 2X24 STRIPS; PROTHROMBIN TIME TEST STRIPS

Catalog Number	04625315160
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Non Reproducible Results (4029)
Health Effect - Clinical Codes	Hematuria (2558); Easy Bruising (4558)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results from the coaguchek vantus meter.On (b)(6) 2025 at 7:30 am, the result was 3.2 inr.At 7:35 am, the result was 2.1 inr.On (b)(6) 2025 at 7:05 am, the result was 1.5 inr.At 7:10 am, the result was 1.9 inr.At 7:15 am, the result was 2.2 inr.On (b)(6) 2025 at 7:15, the result was 2.6 inr.At 7:20, the result was 2.5 inr.At 8:20, the result was 2.0 inr.The therapeutic range was 1.8 to 2.0 inr.The patient "does a routine weekend vegetable meal to maintain normal vitamin k levels".
Additional Manufacturer Narrative
The test strip lot number was 82730324.The expiration date was not provided.The meter and strips have been requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.E3 - occupation was patient/consumer.
Additional Manufacturer Narrative
No products were received for further investigation.There was no data or information provided that reasonably suggests the device malfunctioned.

• Brand Name: COAGUCHEK XS PT TEST 2X24 STRIPS
• Common Device Name: PROTHROMBIN TIME TEST STRIPS
• 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 46250-0457
• MDR Report Key: 24037653
• Report Number: 1823260-2026-00135
• Device Sequence Number: 16072875
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K060978
• 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): 02/13/2026

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: 04625315160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/13/2026
• 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: AZITHROMYCIN (FOR INFECTION TREATMENT); CRESTOR (CHOLESTEROL MEDICATION); LEVALBUTEROL NEBULIZER; TOBRAMYCIN (INTRAVENOUS ANTIBIOTIC); WARFARIN
• Patient Age: 86 YR
• Patient Sex: Male