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

Model Number XS PST

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation and replacement product was sent to the reporter.

Event Description

The initial reporter stated that coaguchek xs meter serial number (b)(4) would not turn on due to an electrical short.The reporter stated there was a puff of smoke with a little smell that came from the meter.There was no evidence of fire and the reporter did not need to evacuate the room.The plastic around the meter contacts was melted.The reporter discarded the batteries.The contacts appeared charred.

Manufacturer Narrative

The customer did not return the meter for investigation.The cause of the event 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: 9720295
• MDR Text Key: 206844475
• Report Number: 1823260-2020-00471
• 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: 03/12/2020

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 Model Number: XS PST
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 01/27/2020
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1