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

Catalog Number 03666794001

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: occupation ni equals lay user / patient.

Event Description

The initial reporter complained of a meter memory issue with their coaguchek xs meter serial number (b)(4) which could lead to the mismatch of historical patient data.The customer initial stated that they were having problems with their meter, that the date wasn't correct, and they saw a result of "8.0." the meter memory was checked.The meter memory showed on (b)(6) 2018 at 6:41 pm a meter result of > 8.0 inr.The customer stated that they have never gotten a result that high and that this result should have read 3.2 inr taken on (b)(6) 2019.The meter memory showed on (b)(6) 2018 at 10:07 am a result of 3.7 inr.The customer stated that this result should have been 3.0 inr taken on (b)(6) 2019.The current date in the meter was showing (b)(6) 2005.There was no allegation of an adverse event.The customer's meter was requested for return.The investigation is currently ongoing.

Manufacturer Narrative

The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause 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: 8688177
• MDR Text Key: 147751542
• Report Number: 1823260-2019-02151
• 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: 07/03/2019

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?: No
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1