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

Catalog Number 03666794001

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer alleged that the screen of the coaguchek xs meter with serial number (b)(6) looked "over heated and deformed." the customer stated the meter would not turn on and the display screen appeared to be burnt and melted.The customer purchased the meter off of the internet and stated he received it in this condition.No adverse event occurred.The device was requested for investigation.

Manufacturer Narrative

The customer returned the meter for investigation.Upon investigation of the returned meter, it was observed that blunt force damage was done to the front of the meter.There were cracks throughout the black screen.Investigation determined the root cause to be customer mishandling.

• 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: 7592321
• MDR Text Key: 111172172
• Report Number: 1823260-2018-01868
• 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: 07/31/2018

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2018
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1