MAUDE Adverse Event Report: ABBOTT INRATIO; TEST, TIME, PROTHROMBIN

Device Problem Insufficient Information (3190)

Patient Problem Transient Ischemic Attack (2109)

Event Type  Injury  

Event Description

The caller stated she suffered a tia when she had an in ratio coagulation meter.No other information was provided.The in ratio device mentioned in this event is not manufactured or imported by our firm.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INRATIO
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 17530321
• MDR Text Key: 321071015
• Report Number: MW5137240
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1