MAUDE Adverse Event Report: ALERE INR RATIO2

Device Problems Nonstandard Device (1420); Incorrect Or Inadequate Test Results (2456)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/06/2015

Event Type  Injury  

Event Description

Remote cardiac services is a terrible company with a bunch of idiots who think that "have a nice day!" is more helpful than efficient delivery of products or services, which can take nearly two weeks to receive supplies and often have mixed up my address with my mother's address in another city.In general, they are a terrible company to work with if, like me, a person is a patient with complex medical problems and multiple blood-clotting problems.They are incompetent and ill-equipped to provide anything but basic "bookkeeping" and i am appalled that medicare pays them! i can email my own inr results to my doctor! i am also reporting the alere home inr ratio2 and their customer service, neither company ever sent me or any of my doctors the letter recalling the product and/or the issues with the ratio2 and it was only my noticing the discrepancies between my home health monitor and my hospital labs at (b)(6) over the course of several months that i went searching online for verification of the problem.In my case, the inaccuracy of the alere inr ratio2 is potentially life-threatening.Their cumulative inefficiency--alere and remote cardiac--is shameful.

• Brand Name: INR RATIO2
• Type of Device: INR RATIO
• Manufacturer (Section D): ALERE
• MDR Report Key: 4408323
• MDR Text Key: 5431189
• Report Number: MW5040152
• 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
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 54 YR
• Patient Weight: 65