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	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter was requested for return.The meter has not been received at this time.Investigation is ongoing.
Event or Problem Description
The initial reporter stated they had a display issue with a coaguchek xs plus meter serial number (b)(4).The meter display has faded segements.Meter displays the roche logo when powered on but the rest of the display has black and white squiggles on it.No misinterpretation of results was reported.
Additional Manufacturer Narrative
The meter was received for investigation.Several screens were checked and the complete display works properly.The device was disassembled for inspection and no contamination or other abnormalities were visible.The reported issue could not be reproduced.The meter is functioning as intended.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: 15294568
• Report Number: 1823260-2022-02567
• Device Sequence Number: 2710999
• 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): 10/10/2022

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: 07/29/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/11/2022
• 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