MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PST CARE KIT; PROTHROMBIN TIME MONITOR

Catalog Number	04837738001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of questionable inr results for one patient tested with the coaguchek xs pst care kit meter.The meter result at 9:44 am was 7.7 inr.The meter result at 9:48 am was 5.7 inr.The patient's therapeutic range is 2.0 inr - 3.0 inr.
Additional Manufacturer Narrative
The test strip lot number is 86944723, with an expiration date of 31-dec-2026.The meter and test strips have been requested for investigation, but have 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 the results have passed the internal inspection.Section e3 - occupation: patient/consumer.

• Brand Name: COAGUCHEK XS PST CARE KIT
• 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
• MDR Report Key: 24895575
• Report Number: 1823260-2026-01451
• Device Sequence Number: 10493772
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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
• Report Date (Section B): 05/19/2026

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: 04837738001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/19/2026
• 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