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

Catalog Number	04625315160
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Medwatch field e1 initial reporter state code - the state was requested, but not provided.Section e3: occupation is patient/consumer.
Event or Problem Description
It was reported that a patient received discrepant results when testing with their doctor's coaguchek xs meter (serial number unknown).A sample from the patient was tested using the doctor's meter, resulting in a value of 2.9 inr.Within 30 minutes of the initial test, a sample from the patient was tested using the doctor's meter, resulting in a value of 4.0 inr.A venous sample collected from the patient at an unknown time on (b)(6) 2025, resulted in a laboratory value of 3.2 inr.The patient's therapeutic range was 3.0 - 3.5 inr.
Additional Manufacturer Narrative
No product was returned for investigation.Medwatch field h6 coding has been updated.

• 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
• MDR Report Key: 23854241
• Report Number: 1823260-2025-05237
• Device Sequence Number: 17416373
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/16/2026

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: Health Professional
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/16/2026
• 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
• Patient Sex: Male