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 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained that she was receiving an error message and had issues with the display on their coaguchek xs meter.Customer stated that the results field was fading and sometimes some of the segments were missing.The customer was advised to perform a display check on the meter and the screen looked clear.The customer was advised to view the meter memory.The customer stated that the results field of the meter memory appeared to be faded in some light and that the segments could have been missing.There was no allegation of an adverse event.The suspect product was requested to be returned for investigation.

Manufacturer Narrative

The customer meter was returned for investigation.The circuit board was contaminated by liquid which has penetrated / corroded solder contacts.A large part of the display segments are only displayed with lower contrast.There are deposits between the conductive rubber and the contacts of the board, which lead to contact failure.The root cause is contamination of the contacts due to improper handling or maintenance.There was not a malfunction of the meter.

• 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: 7505988
• MDR Text Key: 108374791
• Report Number: 1823260-2018-01447
• 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: 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: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 04/13/2018
• Supplement Dates FDA Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1