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

Catalog Number	03666794001
Medical Device Problem Codes	Image Display Error/Artifact (1304); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The test strips' lot number was 71519013 with an expiration date of 31-dec-2024.During the troubleshooting, a display check was performed and revealed the following: 888 appeared clear and complete.The hourglass was faded.The meter memory result appeared faded on the sides.The investigation is ongoing.
Event or Problem Description
We received an allegation about a coaguchek xs meter having a faded display and not detecting the test strips.The reporter stated that they had to tilt the meter in order to see everything on the display because it was faded.The reporter also confirmed that no harm occurred in relation to the display issues because the meter had not been in use since the issues began.
Additional Manufacturer Narrative
The meter was not received for investigation.

• 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: 17853940
• Report Number: 1823260-2023-03153
• Device Sequence Number: 3353364
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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: Health Professional
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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