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

Catalog Number	03666794001
Medical Device Problem Codes	Image Display Error/Artifact (1304); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter was requested to be returned.The investigation is ongoing.
Event or Problem Description
There was an allegation of a display issue with the coaguchek xs meter.The meter displays six marks across the results field.The reporter alleged the marks "look like a speaker but it is going across the results field".A display check was performed and the marks were present in the results fields.
Additional Manufacturer Narrative
The reporter's meter was recived for investigation and the device could not be powered on.The battery contacts and the circuit board were found to be contaminated by liquid (leaked battery) which has penetrated / corroded solder contacts.This contamination affects the battery contacts on the circuit board, which are interrupted, and affects the contacts of the controller.The investigation determined the root cause was contamination of the contacts due to improper handling or maintenance.

• 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: 18103434
• Report Number: 1823260-2023-03566
• Device Sequence Number: 5697880
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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): 12/11/2023

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: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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