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

Model Number COAGUCHEK INRANGE

Device Problems Failure to Transmit Record (1521); Patient Data Problem (3197)

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

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation is patient/consumer.The time and date on the meter was set correctly.The meter was requested for investigation.

Event Description

There was an allegation of a software issue with a coaguchek vantus meter.The meter showed results in the meter memory that the patient did not remember receiving.The meter memory showed the following results: on (b)(6) 2022 the result at 9:27 a.M.Was 2.5 inr.The patient remembers receiving this result.On (b)(6) 2022 the result at 12:54 p.M.Was 3.9 inr.On (b)(6) 2022 the result at 9:14 p.M.Was 4.2 inr.On (b)(6) 2022 the result at 1:18 p.M.Was 4.8 inr.On (b)(6) 2022 the result at 10:17 a.M.Was > 6.0 inr.On (b)(6) 2022 the result at 10:25 a.M.Was > 6.0 inr.The patient did not remember receiving any of the results listed between (b)(6) 2022.All of the results between (b)(6) 2022 were sent to the patient¿s doctor at once via the remote inr mobile app.The patient's therapeutic range is 2.5 - 3.0 inr.

Manufacturer Narrative

The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.The customer confirmed internet problems because of an ice storm.This communication and transfer of the result by the app was possibly interrupted due to the ice storm.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13549880
• MDR Text Key: 292483369
• Report Number: 1823260-2022-00417
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2022
• 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
• Treatment: WARFARIN
• Patient Sex: Female