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 Consequences Or Impact To Patient (2199)

Event Date 08/07/2018

Event Type  malfunction  

Event Description

The customer stated the numbers were flickering on the display of her meter.While troubleshooting with customer support, a display check was performed and no segments of the display were missing.The customer stated that for the three 8s that are supposed to be displayed during the display check, only one of the 8s were flickering.The customer stated her meter result of 1.4 inr was flickering.She also stated the result changed from 1.4 inr to 0 inr back to 1.4 inr.This issue could affect the interpretation of patient results.There was no allegation of an adverse event or of any results being incorrectly interpreted.The suspect meter was requested to be returned for further investigation.

Manufacturer Narrative

The customer returned the meter for investigation.The display shows no error and no missing or faint segments.The circuit board shows no contamination.The investigation did not identify a product problem.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: 7836770
• MDR Text Key: 118892904
• Report Number: 1823260-2018-02932
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• 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: 12/13/2018

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: 11/15/2018
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 08/07/2018
• Supplement Dates FDA Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1