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

Model Number COAGUCHEK INRANGE

Device Problems Display or Visual Feedback Problem (1184); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  malfunction  

Event Description

We received an allegation of a display problem on a coaguchek vantus meter.It was reported that the meter had to be shaken to obtain a result.The customer stated that the meter first displayed an m-42 error.Per product labeling, this error indicates "not enough sample was applied.Repeat test with a new test strip." the meter was shaken with the same test strip in the meter and then a result of 1.7 inr was displayed.The meter memory was checked which showed the result of 1.7 inr.A display test was performed successfully.The strip lot is 58944025 and the expiration date is 31-aug-2023.

Manufacturer Narrative

Occupation is patient/consumer.The meter was requested for investigation.Replacement product was sent.

Manufacturer Narrative

The meter was provided for investigation.The investigation found that the circuit board showed no defects or contamination that could lead to the complaint error.Test measurements carried out on the meter did not show any errors and the alleged event could not be reproduced.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 15591172
• MDR Text Key: 307027321
• Report Number: 1823260-2022-03139
• 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
• Report Date: 11/21/2022

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
• 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: 09/16/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 11/21/2022
• 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