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

Catalog Number	05021537001
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's meter was requested for investigation.
Event or Problem Description
The initial reporter stated there was an issue with the display of coaguchek xs plus meter serial number (b)(4).The meter had segments that were missing from the results field of the display.The issue impeded the customer's ability to read the results field of the display.It was noted there were lines on the display and rainbow like colors also appeared on the display.The facility has not mis-reported results due to the issue.The meter has not been used since the issue was noticed.The battery compartment of the meter was not soiled and the customer has noted there was no misuse of the meter.
Additional Manufacturer Narrative
The customer's meter was provided for investigation.During the investigation, the display stayed white after turning on the meter.Only the backlight was working and there were no characters shown on the display.The meter booted up correctly and no external damage was visible.The display issue impeded the visibility of the complete screen, not specifically the results field.The meter was disassembled.A visual inspection of the electronic parts showed no abnormalities and no contamination was found.The meter display was found to be defective.No loose contact or bad solder joint could be detected on the display unit.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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14840183
• Report Number: 1823260-2022-01875
• Device Sequence Number: 4743862
• 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
• Report Date (Section B): 08/26/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/26/2022
• 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