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

Catalog Number	04837738001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The coaguchek xs pt test 6 strip lot number is 80257722, and the expiration date is 28-feb-2026.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 product was requested for investigation and has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.
Event or Problem Description
There was an allegation of a questionable inr result using the coaguchek xs pt test 6 strip with the coaguchek xs pst care kit for one patient.The initial result at 6:41 pm was 4.3 inr, and another result at 6:55 pm was 5.6 inr.The patient was not sure if her hands were completely dry when doing the first test.
Additional Manufacturer Narrative
Medwatch section d9 device available for evaluation, device returned to mfr, date device returned, and h3 device evaluated by mfg were updated.The reporter's meter was provided for investigation, where it was tested using retention strips and retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 2.7 inr.Qc 2: 2.7 inr.Qc 3: 2.8 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 investigation found that the returned and the retention material meet the specification, and there was no product issue found.

• 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: 24009889
• Report Number: 1823260-2026-00112
• Device Sequence Number: 4888324
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/13/2026
• 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: GABAPENTIN.; MEDICATION FOR DIABETES.; TYLENOL.; WARFARIN.
• Patient Sex: Female