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

Model Number XS PST

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 07/05/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

There was an allegation of a display issue with a coaguchek xs meter.The 3 digit numerical code of 456 appeared as "h56".A display check was completed and no segments were missing.A strip was inserted to turn on the meter and the code of 456 was blinking; between the blinking 456, "rrr" was displayed.The user moved out of direct bright light and still saw 456 and "rrr" blinking alternately on the display screen.The 456 no longer displayed as "h56".No results were misinterpreted due to this issue.The results in the meter memory were 1.5 inr on (b)(6) 2021, 1.8 inr on (b)(6) 2021 and 2.0 inr on (b)(6) 2021.These results were correct as the user remembered them.

Manufacturer Narrative

The customer's meter was received for investigation.The meter¿s circuit board was tested for damage or contamination and it was found the circuit board was contaminated.The root cause is determined to be contamination of the conductive rubber contacts due to improper handling or maintenance by the customer.

• 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: 12247115
• MDR Text Key: 264123143
• Report Number: 1823260-2021-02224
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• 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: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Date Manufacturer Received: 07/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1