MAUDE Adverse Event Report: INR TEST, TIME, PROTHROMBIN

Device Problem Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2020

Event Type  Injury  

Event Description

(b)(6) reported to us an inr value of 3.7 dated (b)(6) 2020.The pt called in her inr on (b)(6) 2020 of 3.7.(b)(6) called the pt on (b)(6) 2020 and dated the value from that day.I called pt - she did not test on (b)(6) 2020, but on (b)(6) 2020.It seems the company relies on data as obtained directly by the pt versus via downloading the inr results.I have made multiple attempts (phone, email) to contact the company with no success.Fda safety report id# (b)(4).

• Brand Name: INR TEST, TIME, PROTHROMBIN
• Type of Device: INR TEST, TIME, PROTHROMBIN
• MDR Report Key: 9840015
• MDR Text Key: 184055162
• Report Number: MW5093772
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2020

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 75