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

Catalog Number	05021537001
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated there was an issue with the coaguchek xs plus user interface.The specific date of the event is not known and started occurring approximately on (b)(6) 2022.The reporter stated the meter no longer asks for the operator id.Additionally, when a patient id is entered, the meter will start typing letters on its own, even when the operator is not pressing anything on the screen.No discrepancies were observed upon meter power up and the display is complete.The reporter tried accessing the meter set up to verify whether the operator id is disabled.The meter populated an administrator box and requested a password.The reporter was provided the password of the day, but the meter rejected the password.Further attempts to enter a password were not successful.The reporter was instructed to access the main menu and access "patient test".The reporter was able to enter various letters and all letters selected by the reporter were entered.The typing issue could not be recreated.
Additional Manufacturer Narrative
The reporter's meter was requested for investigation and a replacement meter was sent to the reporter.
Additional Manufacturer Narrative
The meter was not returned for investigation, so no further investigations were possible.The investigation could not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The meter was returned for investigation.After booting the device the input of an operator id is requested.It was observed that an entry is made without operating the touchpad.The behavior alleged by the customer could be confirmed.There were no traces of an obvious mechanical impact visible on the housing of the device.The device was disassembled and a visual inspection of the electronic parts found no abnormalities or contamination.The flex cable connection was checked and found to be correct.The returned display assembly was replaced with a fully functional display assembly.The meter performed as expected with the exchanged display.The meter display assembly was found to be defective.Medwatch fields d9 and h3 have been updated.

• Brand Name: COAGUCHEK XS PLUS
• Common Device Name: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15670669
• Report Number: 1823260-2022-03354
• Device Sequence Number: 6320916
• Product Code: GJS
• UDI-Device Identifier: 00365702164109
• UDI-Public: 00365702164109
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 12/13/2022

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: 05021537001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 11/14/2022; 11/25/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/15/2022; 12/13/2022
• 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