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

Catalog Number 03666794001

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient stated that the segments in the result field of the coaguchek xs meter display were fading.The customer performed a display check and segments were missing from the left "8" of the result field, so that the value appeared to be a "2".There was no allegation of an adverse event due to using this meter.The patient's meter was requested for investigation.

Manufacturer Narrative

The meter was returned for investigation.Upon investigation of the returned meter, conductive rubber was found to be improperly adjusted.

• 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: 7521561
• MDR Text Key: 108502047
• Report Number: 1823260-2018-01520
• 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: 07/13/2018

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: 06/29/2018
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 04/30/2018
• Supplement Dates FDA Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1