MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST 1X24 STRIPS; PROTHROMBIN TIME MONITOR

Catalog Number	04625358160
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The coaguchek test strips' lot number and expiration date were not provided.The device was requested for investigation.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.Section e3: occupation is patient/consumer.The investigation is ongoing.
Event or Problem Description
We received an allegation of a questionable high inr result for one patient tested with the coaguchek xs pst meter, when compared with another coaguchek meter.The meter result at the doctor's office was 2.5 inr, while the patient's meter result was 5.0 inr.The time difference between the measurements was within minutes.The patient¿s therapeutic range was not provided.
Additional Manufacturer Narrative
Medwatch fields d1, d2a, d2b, d4 and g4 were updated.The customer's coaguchek devices were not received for investigation.The cause of the event could not be determined.The investigation did not identify a product problem.
Additional Manufacturer Narrative
This event was previously reported under medwatch 1823260-2025-04834 with g3 date received by mfg date of 05-nov-2025.

• Brand Name: COAGUCHEK XS PT TEST 1X24 STRIPS
• 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 46250-0457
• MDR Report Key: 24036054
• Report Number: 1823260-2026-00129
• Device Sequence Number: 10472337
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 04/08/2026

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: 04625358160
• 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: 01/29/2026; 04/02/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/23/2026; 04/08/2026
• 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: Unknown