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

Model Number	COAGUCHEK INRANGE
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's meter was requested for investigation and a replacement product was sent to the customer.Medwatch field occupation - the occupation is patient/consumer.
Event or Problem Description
It was alleged that there was an issue with the display of coaguchek vantus meter serial number (b)(4).The customer could not clearly see the results in the results field of the meter display.A color display test was performed on the meter and it displayed the colors as it should.The customer advised she saw six numbers across the screen, such as "62489" and that it was not showing her inr result.At around 2:00 p.M.On (b)(6) 2023, the customer measured a value of 2.6 inr on the meter.When checking the meter's patient result memory, this value was not observed.
Additional Manufacturer Narrative
The reporter¿s meter was provided for investigation where it was tested using retention test strips and retention controls.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.8 inr.Qc 2: 2.8 inr.Qc 3: 2.8 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The results alleged by the customer were observed in the meter¿s patient result memory.Upon review of the meter memory, the alleged value of 2.6 inr was observed on (b)(6) 2023, not on (b)(6) 2023.The obtained qc values were observed in the meter memory without issues.No meter memory issues were observed.Values were saved according to date and time.The investigation could not identify a product problem.The cause of the event could not be determined.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: 16744788
• Report Number: 1823260-2023-01267
• Device Sequence Number: 12444203
• 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): 05/04/2023

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
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/04/2023
• 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