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 02/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of damage to her coaguchek xs meter and issues with the display.On (b)(6) 2018 the customer's meter initially would not power on and there were no signs of an electrical shortage.She replaced the batteries, set the meter, and tested successfully.At approximately 5 pm to 6 pm, the customer obtained a result of 2.1 inr.The customer stated that she did not believe there were any missing segments of the results area of the screen and did not perform a full screen display.The customer's coumadin was the same and no further action was taken after the results were obtained.On (b)(6) 2018 the customer stated she heard rattling when she removed the meter from its case.She observed that the "ir" port was "ajar" and removed it.She stated that the meter displayed intermittent power, two dashes, and could not be used.There was no sign of electrical shortage, burning, melting, or smoking from the meter.She stated that the meter beeped irregularly after pressing power.Based on the meter not displaying a complete field, a full screen display was attempted.There were no segments in the results area, the meter beeped, and nothing displayed.The customer stated that the missing segments could have led to a misinterpretation of the results.The customer then questioned her previous results obtained on (b)(6) 2018.The customer could not confirm if the results were set to inr because the display was not available.The meter had not been cleaned and did not appear soiled.The customer's hematocrit was in range, no heparin, no antiphospholipid antibodies, and no direct thrombin inhibitor.The customer had no changes to coumadin, no additional medication changes, no illness, and no dietary changes.The customer had no high results.There was no allegation of an adverse event.The suspect product was requested to be returned for investigation.

Manufacturer Narrative

The device was returned for investigation.Sections were updated.The "ir" window was damaged due to increased force but does not influence the device function.The root cause of the issue was due to contamination of the contacts due to improper handling/maintenance.

• 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: 7363214
• MDR Text Key: 103530207
• Report Number: 1823260-2018-00896
• 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: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• 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: 04/09/2018
• Date Manufacturer Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN