MAUDE Adverse Event Report: ALERE ALERE IN RATIO 2 PT/INR; PROFESSIONAL TEST STRIPS

Lot Number 99008G2

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

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 04/16/2014

Event Type  Injury  

Event Description

Use of inr test strips to monitor inr/coumadin adjustments.Adverse event occurred, later found out the test strips were recalled.On (b)(6) 2014, pt seen in office following hospital discharge for anticoagulation management.Pt released from hosp following cva (infarct) and vertebral artery dissection.Inr test strip used (later found to recalled).Pt was on lovenox to bridge until coumadin inr of 2-3.Inr was 1.6 coumadin dosage adjusted to take 10 mg twice weekly, 7.5 mg 5 x weekly.On (b)(6) 2014, inr test strip used (later found to be recalled) inr 1.4 coumadin adjusted to 10 mg 4 x per week, 7.5 mg 3 x weekly.On (b)(6) 2014, inr test strips used again (recalled batch) inr - 1.6 inr/pt blood test ordered.Discontinued lovenox and reduced coumadin to 10 mg 3 x week and 7.5 mg 4 x weekly, based on pts report of an inr of 3.3 at his work.Inr/pt laboratory value was 3.2 on (b)(6) 2014, at 8:06 pm.Our office received a fax statement recalling the test strips-alere inratio batch pn 99008g2.Our office had been using this lot number for the last several weeks.On (b)(6) 2014, pt admitted with intracerebral hemorrhage and discharged on (b)(6) 2014.All pts receiving an inr with the recalled test strips were called and inr/pt lab test was performed.On (b)(6) 2014, our office received via certified mail the urgent product recall notification letter.Reason for use: use of inr test strips to monitor inr/coumadin adjustments.

• Brand Name: ALERE IN RATIO 2 PT/INR
• Type of Device: PROFESSIONAL TEST STRIPS
• Manufacturer (Section D): ALERE
• MDR Report Key: 3803031
• MDR Text Key: 18867788
• Report Number: MW5035958
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2014

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: Other
• Device Lot Number: 99008G2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Weight: 80