MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK VANTUS; PROTHROMBIN TIME MONITOR

Catalog Number 07729952160

Device Problems Image Display Error/Artifact (1304); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

The meter was requested to be returned for investigation.

Event Description

There was an allegation of a display issue with the coaguchek vantus meter.The user alleged the display "looks like green christmas tree" and had some colored lines but nothing else.The meter allegedly did not have the main menu displayed and the user was unable to perform a display check.

Manufacturer Narrative

The meter was received for investigation.After starting the device, the display stayed completely white the device data and fault memory can not be read out because of the display.The allegation was substantiated by visual investigation.The removed display showed half-round cracks at the bottom edge of the glass near the cable connection area.The alleged colored lines on the display result from the cracks in the display glass.The device could not be operated, no measurements could be performed, and no results could be displayed.Therefore, there was no risk of a result misinterpretation.

• Brand Name: COAGUCHEK VANTUS
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17930556
• MDR Text Key: 325607800
• Report Number: 1823260-2023-03288
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702700499
• UDI-Public: 00365702700499
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 07729952160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 94 KG