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

Model Number XS PST

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation is lay user/patient.The meter was requested for investigation.

Event Description

The initial reporter complained of a display issue with a coaguchek xs meter.The customer replaced the batteries because the meter was "not acting normal." the customer alleged the display screen was faint.Upon completing a display check, the whole screen was dim and the customer had difficulty seeing the "88.8"s in the results field.

Manufacturer Narrative

The reporter's device was returned for investigation.During the investigation, several screens were checked and the complete display works properly.No malfunction could be detected.The mentioned problem could not be reproduced.The device has been disassembled and its electronic compartment has been visually inspected.No contamination or other abnormalities are visible.No root cause or any other evidence for missing segments were found.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10395054
• MDR Text Key: 202536967
• Report Number: 1823260-2020-01960
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: XS PST
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1