MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST 6 STRIP; PROTHROMBIN TIME TEST STRIPS

Catalog Number	04625374160
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's therapeutic range was 2.0 -3.0 inr.
Additional Manufacturer Narrative
The meter and test strips were requested for investigation.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.Section e3: occupation is patient/consumer.
Event or Problem Description
It was reported that a patient received questionable results when testing with coaguchek xs meter serial number (b)(6).Please refer to the attachment for all patient data.Clarifications have been requested for all information written in red.
Additional Manufacturer Narrative
When the patient was hospitalized after receiving the 12 inr result on (b)(6) 2026, the patient was treated with vitamin k.The customer did not pay attention to her inr until she got out of the hospital.She only remembers her last meter reading which was 1.6 inr or 1.8 inr.The patient received a new meter on an unknown date and with the new meter, she had a result of 3.2 inr on (b)(6) 2026 at 8:42 p.M.The patient was satisfied with the new meter.It was mentioned the patient had "burses".This means the patient had bruises.The patient mentioned she had bruised due to "prodding and probing".The bruises have now faded.At 4:52 on 26-mar-2026, the patient had a result of 1.6 inr using an unknown method.The reporter's meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 3.0 inr, qc 2: 3.0 inr, qc 3: 3.0 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The returned customer material, as well as the corresponding retention material meet the specifications.Medwatch field d9 has been updated.

• Brand Name: COAGUCHEK XS PT TEST 6 STRIP
• 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: 25056411
• Report Number: 1823260-2026-01711
• Device Sequence Number: 13253141
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 05/22/2026

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: 04625374160
• Device Lot Number: 86944723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 04/03/2026; 05/06/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/01/2026; 05/22/2026
• 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: COUMADIN; JANTOVEN/GENTAVIN/GENTAVAN; LOVENOX; WARFARIN
• Patient Sex: Female