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

Model Number COAGUCHEK INRANGE

Device Problem Image Display Error/Artifact (1304)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

The customer complained of a display issue with coaguchek vantus meter serial number (b)(4).The customer states the meter display gets dim after powering on.No segments are missing from the results field but the results field is difficult to read due to the screen being dim.No misinterpretation of results was reported.

Manufacturer Narrative

Occupation is patient/consumer the meter has been requested for investigation.The investigation is ongoing.

Manufacturer Narrative

The meter was returned for investigation.The returned meter was powered on and it was confirmed the backlight was very dim.The assembly and contacting of the display are correct.No customer mishandling or user error was observed.The display was replaced with a retention display and the meter performed as intended.The original meter display was determined to be defective.Medwatch fields d9 and h3 have been updated.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15969561
• MDR Text Key: 308462655
• Report Number: 1823260-2022-03992
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702700499
• UDI-Public: 00365702700499
• Combination Product (y/n): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

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 Model Number: COAGUCHEK INRANGE
• Device Catalogue Number: 07729952160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 02/09/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1