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

Catalog Number 05021537001

Device Problem Image Display Error/Artifact (1304)

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

Event Date 07/29/2022

Event Type  malfunction  

Manufacturer Narrative

The meter was requested for return.The meter has not been received at this time.Investigation is ongoing.

Event 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.

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
• 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: 15294568
• MDR Text Key: 302021440
• Report Number: 1823260-2022-02567
• 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
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• 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