MAUDE Adverse Event Report: ALERE PT/INR TEST STRIPS

Lot Number 332959

Device Problem Low Test Results (2458)

Patient Problem Overdose (1988)

Event Type  Other  

Event Description

Gave lower inr totals, thereby requiring an increase in anticoagulant dosage which resulted in an actual overdose causing a bleeding potential.

• Brand Name: PT/INR TEST STRIPS
• Type of Device: PT/INR TEST STRIPS
• Manufacturer (Section D): ALERE
• MDR Report Key: 3842887
• MDR Text Key: 4685969
• Report Number: MW5036367
• 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: 05/26/2014

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: Health Professional
• Device Expiration Date: 01/31/2015
• Device Lot Number: 332959
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2014
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 88