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

Catalog Number 03666794001

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation - the occupation is lay user/patient.

Event Description

The custom stated that his coaguchek xs meter was smoking, caught fire, and melted.The customer was attempting to use the meter and had inserted a test strip when the issue occurred.There was no allegation of an adverse event.The device was requested to be returned for investigation.

Manufacturer Narrative

The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.

• 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: 8282580
• MDR Text Key: 134355451
• Report Number: 1823260-2019-00339
• 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: 03/13/2019

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?: No
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1