MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME MONITOR

Catalog Number	03666794001
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Inadequate User Interface (2958); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a software issue that affected the display of the coaguchek xs meter.Per the meter memory, the result at 7:51 am was >8.7 inr.This result was outside of the meter¿s measuring range.Per product labeling for the device: the coaguchek xs pt test strips provide test results in the measuring range of 0.8 to 8.0 inr.
Additional Manufacturer Narrative
The time and date were not set correctly on the meter at the time of the tests.The meter memory was checked and the customer was confident that the result displayed was >8.7 inr.A display check was performed and it was confirmed there were no missing segments from the results area of the display.The meter was requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.
Additional Manufacturer Narrative
As no customer material was received, further investigation was not possible.The investigation could not confirm a product malfunction.
Additional Manufacturer Narrative
Medwatch fields d9 and h3 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: 2.7 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 date and time on the meter were not set correctly.No results of >8.7 inr were observed in the meter's patient result memory.Two results of >8.0 inr were observed on a date of (b)(6) 2001 and one result of >8.0 inr was observed on a date of (b)(6) 2001.If the meter shows inr > 8, the measurement is out of the meter´s measuring range.The allegation that the meter was displaying and storing a result above the reading range was not substantiated.The returned and the retention material met the specifications.No product issue was found.

• Brand Name: COAGUCHEK ® XS SYSTEM
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21535707
• Report Number: 1823260-2025-00646
• Device Sequence Number: 12726893
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/18/2025

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: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 03/24/2025; 04/16/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/24/2025; 04/18/2025
• 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