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

Model Number	COAGUCHEK INRANGE
Medical Device Problem Codes	Failure to Transmit Record (1521); Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation is patient/consumer.The time and date on the meter was set correctly.The meter was requested for investigation.
Event or Problem 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.
Additional 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
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13549880
• Report Number: 1823260-2022-00417
• Device Sequence Number: 5236177
• 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): 04/14/2022

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 04/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WARFARIN
• Patient Sex: Female