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

Model Number XS PST

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation and replacement product was sent to the reporter.Occupation - the occupation is lay user/patient.

Event Description

The initial reporter stated there was an issue with the display of coaguchek xs meter serial number (b)(4).The reporter had just replaced the batteries to the meter with 4 new duracell batteries.The reporter stated she turned the meter on and saw all items on the display and it was all flashing.The meter beeped multiple times and did not proceed to test mode.The reporter removed the batteries and the battery compartment was clean and dry, with no corrosion.The reporter cleaned the battery contacts of the meter with a pencil eraser.The reporter then performed a display check of the meter and segments were missing from the results field of the display.

Manufacturer Narrative

The customer's meter was received for investigation.The display shows no error during investigation.The meter¿s circuit board was tested for damage or contamination and it was found the printed circuit board (pcb) was contaminated.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.Medwatch fields d9 and h3 were updated.

• 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: 10335432
• MDR Text Key: 200801294
• Report Number: 1823260-2020-01805
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• 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: 09/17/2020
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1