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

Catalog Number 03666794001

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that segments were missing from the results area in the display area of the coaguchek xs professional meter.The customer stated that the meter displayed an error and it would not turn on.There were no batteries in the meter and the battery compartment was corroded.The customer was advised to clean the battery compartment.The customer installed new batteries and turned the meter on.The issue occurred when the customer performed the display test.There was no allegation of an adverse event.The device was requested for investigation.

Manufacturer Narrative

The customer meter was returned for investigation.The circuit board is contaminated by liquid which has penetrated / corroded solder contacts.Deposits of penetrating liquid on the board could be seen which caused the complaint error.The root cause is contamination of the meter due to improper handling or maintenance.There was no malfunction of the device.

• 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: 7450727
• MDR Text Key: 107084017
• Report Number: 1823260-2018-01253
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

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: Health Professional
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1