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

Model Number	COAGUCHEK INRANGE
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's meter was requested for investigation.
Event or Problem Description
It was reported that there was an issue with the display of coaguchek vantus meter serial number (b)(4).The meter display was entirely black, but a test could still be performed and the result could be transmitted wirelessly.The batteries were replaced, but the meter display remained entirely black.A display test could not be performed.The meter was not dropped or exposed to liquids.
Additional Manufacturer Narrative
The meter was returned for investigation.The device could be switched on, but the display remained dark.The tone of the beeper and the signal of an error message could be heard.A replacement display showed the same error.The display symbols could be seen on closer inspection of both displays.The backlight of the meter failed due to a defect of the circuit board or electronic component on the circuit board.Medwatch fields d9 and h3 have been updated.

• 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: 15312638
• Report Number: 1823260-2022-02612
• Device Sequence Number: 2710649
• 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 Model Number: COAGUCHEK INRANGE
• 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: 08/03/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 08/29/2022
• 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: Unknown