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

Catalog Number	07729952160
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation is patient/consumer.The meter was requested for investigation.The customer changed the batteries prior to calling, but the issue of the dark screen persisted.The battery compartment and the strip guide were clean.The customer routinely cleans the strip guide with the approved solution, even though it has not been contaminated.The customer was advised to clean the strip guide only when contaminated.The customer routinely changes batteries when one bar of power remains on battery icon.
Event or Problem Description
We received an allegation of a display issue with a coaguchek vantus meter.The meter went dark, and the patient could not see the screen properly.On (b)(6) 2022 the customer was able to complete the test and see the result of 2.7 inr without issue.The customer did not question this result.The customer states that she was unable to access the options to transfer the result because the meter screen went dark.She turned the meter on and she could see it light up, but was unable to see the menu options.She turned the meter on again and was unable to see display because it was darker than before.
Additional Manufacturer Narrative
The meter was received for investigation.After starting the device, the display stayed black.Due to the lack of background lighting, the display is not visible and cannot be operated.No misinterpretation of results is possible.The cause was determined to be a defect in the 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: 15179635
• Report Number: 1823260-2022-02329
• Device Sequence Number: 6302122
• 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): 09/22/2022

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: 07/12/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/23/2022
• 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: Female