MAUDE Adverse Event Report: HEMOSENSE INC INRATIO; PTT

Device Problems Low Test Results (2458); Defective Device (2588)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Type  No Answer Provided  

Event Description

The caller reports that her husband rented an outdated device about a year ago for regular prothrombin test time checks.This device always gave low results which caused her husband to wrongly dose himself thus causing him to wound and bleed easily all the time.At one time it was very bad; the husband suffered an infection and was hospitalized.The doctor had to perform surgery on him and when the doctor tested him, his inr was too high.Meanwhile his inr was normal when tested with the old rented device.The surgery was postponed.This was reported to the company which rented out the device.They later sent a letter asking for the device to be shipped back so that a new one can be issued.The reporter was very upset, reporting the company intentionally gave the husband an old defective machine which could have led to his death.She would like the fda on investigate the company rcs (remote cardiac services) (b)(4).She is concerned the company might have sold to more people the old defective devices.

• Brand Name: INRATIO
• Type of Device: PTT
• Manufacturer (Section D): HEMOSENSE INC
• MDR Report Key: 3709418
• MDR Text Key: 4335404
• Report Number: MW5035281
• Device Sequence Number: 1
• Product Code: GJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/27/2014

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2014
• Patient Sequence Number: 1