MAUDE Adverse Event Report: ALERE ALERE INRATIO2 PT/INR STRIPS; PROTHROMBIN TIME TEST

Lot Number PN 99008G2

Device Problem Defective Component (2292)

Patient Problem Test Result (2695)

Event Date 05/06/2014

Event Type  malfunction  

Event Description

Pt's inr was subtherapeutic.After defective strips were replaced, pt's inr was supratherapeutic.Date of use: (b)(6)2014.Diagnosis or reason for use: pt on warfarin therapy for pulmonary embolism.Event abated after use stopped or dose reduced: yes.

• Brand Name: ALERE INRATIO2 PT/INR STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE
• MDR Report Key: 3820280
• MDR Text Key: 4447982
• Report Number: MW5036131
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: PN 99008G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: METOPROLOL TARTRATE 25 MG 1/2 TABLET TWICE DAILY; LEXAPRO 10 MG DAILY; LIPITOR 80 MG DAILY; PHENYTOIN 100 MG 2 CAPSULES TWICE DAILY; ASPIRIN 81 MG DAILY; DOCUSATE 100 MG TWICE DAILY; WARFARIN 10 MG; ADVAIR DISKUS 250/50 1 INHALATION TWICE DAILY; FAMOTIDINE 20 MG TWICE DAILY; BACLOFEN 10 MG 1/2 TABLET EVERY 6 HOURS; KEPPRA 500 MG 2 TABLETS TWICE DAILY; LISINOPRIL 2.5 MG DAILY
• Patient Age: 44 YR