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 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

There was no corrosion in the battery well of the meter.The meter was requested for investigation.

Event Description

We received an allegation of a display issue with a coaguchek vantus meter.When the patient turned the meter on to run a test, 3 one-inch-long black vertical "blobs" were across the display screen.The lines were frozen on the display screen and the meter would not proceed to run a test.No tests could be run on the meter.When the patient tested on the meter approximately 2 months ago the display screen was "fine" and the results could be read clearly.There were no missing segments on the display screen at that time.

Manufacturer Narrative

The customer did not return the meter for investigation.As no product was returned, a specific root cause could not be determined.

Manufacturer Narrative

Sections d9 and h3 were updated.The meter was received for investigation.Upon powering on the device, the display remained white with some black spots caused by visible cracks in the display screen.The device did not show any damage suggesting external force (damage from being dropped).The display has completely failed and no results can be displayed.Half-round cracks were observed at the bottom edge of the screen.

• 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: 15869382
• MDR Text Key: 307802464
• Report Number: 1823260-2022-03772
• 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,Followup
• Report Date: 02/24/2023

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: 10/31/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 12/12/2022; 02/15/2023
• Supplement Dates FDA Received: 12/19/2022; 02/24/2023
• 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
• Patient Sex: Male