MAUDE Adverse Event Report: HEMOSENSE

Device Problems Incorrect Or Inadequate Test Results (2456); Structural Problem (2506)

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

Event Date 06/22/2006

Event Type  malfunction  

Event Description

Regarding the hemosense inratio pt/inr monitor system: inaccurate use of test strips due to design.Hanging blood drop needed to be placed on small test (well) area.Frequent corruption of test strip by difficulty in aligning the blood drop to test area.New device design necessary to ensure accurate readings.Recommended device by medical professional is coaguchek xs brand.

• Brand Name: HEMOSENSE
• Type of Device: HEMOSENSE
• MDR Report Key: 4412586
• MDR Text Key: 5283544
• Report Number: MW5040168
• Device Sequence Number: 1
• Product Code: GJS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/07/2015

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2015
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 52