MAUDE Adverse Event Report: ALERE ALERE

Model Number INRATIO 2PT/INR MONITOR

Device Problems Incorrect Or Inadequate Test Results (2456); Defective Device (2588)

Patient Problems Dyspnea (1816); Hemorrhage/Bleeding (1888); Nausea (1970)

Event Date 11/19/2014

Event Type  Injury  

Event Description

Client's son called and stated that client has been on the device for a long time.He says the device always shows that the inr ratio is within range, which is between 2-3, meanwhile it has been giving false readings due to defective strips.He states that on (b)(6) 2014, client had a hard time breathing, was nauseous and bled from mouth, nose, and arms.She was taken to the hospital.While at hospital client's inr ratio was monitored constantly, oxygen therapy was given, stents put in place.Client was later discharged on (b)(6) 2014.Son stated that her pcp ordered for a nurse to come once a week to check take blood for lab works.The last inr was 2.6 (on (b)(6) 2015).He indicated that the device used by the nurse was same device used by (b)(6).Son stated he contacted alere who told him a replacement just like what stanford uses will be sent to replace the old one.Also, he states that alere wants him to ship the old device and the strips.He expressed concerns about not being sure of sending the old device to them and that is why he was calling to give this report.He stressed on the fact that last friday the (b)(6) 2015 was the last visit from the nurse.

• Brand Name: ALERE
• Type of Device: ALERE
• Manufacturer (Section D): ALERE; san diego
• MDR Report Key: 4475920
• MDR Text Key: 15329524
• Report Number: MW5040519
• 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: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: INRATIO 2PT/INR MONITOR
• Device Catalogue Number: 122832605
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 79 YR
• Patient Weight: 68