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

Catalog Number 05021537001

Device Problems Display or Visual Feedback Problem (1184); No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The reporter's meter was requested for investigation and a replacement meter was sent to the reporter.

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.

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
• Type of Device: 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
• MDR Text Key: 306725895
• Report Number: 1823260-2022-03354
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702164109
• UDI-Public: 00365702164109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 05021537001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 11/14/2022; 11/25/2022
• Supplement Dates FDA Received: 11/15/2022; 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1