MAUDE Adverse Event Report: Roche Diagnostics COAGUCHEK XS PT TEST 6 STRIP; PROTHROMBIN TIME TEST STRIPS

Catalog Number	04625374160
Medical Device Problem Codes	No Device Output (1435); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable inr results for 1 patient using the coaguchek xs pt test 6 strip on a coaguchek xs pst care kit.The patient provided the following results: 1.2 inr, 1.0 inr , 1.1 inr , 1.3 inr , 1.6 inr, 2.4 inr.The patient stated that the results were obtained before her hospitalization on (b)(6)2026.The specific dates and times of the results were requested, but not provided.The patient tests on the meter every two days.The therapeutic range is 2.0 to 3.0 inr.
Additional Manufacturer Narrative
The coaguchek xs pst care kit serial number is (b)(6).Section e3 - occupation: patient/consumer.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 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.The patient stated that they have anti-phospholipid antibodies (apas).Per product labeling, "the presence of anti¿phospholipid antibodies (apas) such as lupus antibodies (la) may lead to prolonged clotting times, i.E., they may cause false¿high inr values.If you have or suspect that you have apas, discontinue testing until you discuss with your physician.".

• 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 -045
• 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: 50898164
• Report Number: 1823260-2026-03951
• Device Sequence Number: 10706211
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 92244227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/25/2026
• 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: Female
• Patient Weight: 130 LB