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

Catalog Number	07729952160
Medical Device Problem Codes	Display Difficult to Read (1181); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of a display issue with a coaguchek vantus meter.The customer stated there were black lines throughout "most parts" of the display screen and there was a black circle in the lower right corner.A display check was performed and the same observation was made.The last results were checked and the customer could not make out the result due to the display issue.
Additional Manufacturer Narrative
Occupation is patient/consumer.The meter was requested to be returned for investigation.
Additional Manufacturer Narrative
The customer's returned meter was powered on using fresh retention batteries.A crack on the bottom just right of the center of the display could be seen.Meter has been dropped.The fracture pattern indicates user error is the cause of the cracked display.

• Brand Name: COAGUCHEK VANTUS
• Common Device Name: 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: 15188184
• Report Number: 1823260-2022-02364
• Device Sequence Number: 6341062
• Product Code: GJS
• UDI-Device Identifier: 00365702700499
• UDI-Public: 00365702700499
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 07729952160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown