MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 100071

Device Problem Low Test Results (2458)

Patient Problems High Blood Pressure/ Hypertension (1908); Tachycardia (2095)

Event Date 07/04/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inratio inr result in comparison to the laboratory inr result.On 07/04/2014, the pt reported that the inratio inr was 3.4, 3.0 and 7.5.The pt's therapeutic range was 2.5 - 3.5.All testing performed within twenty mins.On (b)(6) 2014, the pt experienced an increase in heart rate with a blood pressure of 180/95 and visited the emergency room.In the emergency room, the laboratory inr was 14.9 and the pt was administered vitamin k.After twenty (20) hrs the laboratory inr was 4.0 and the pt was released from the emergency room.There was no add'l info provided.

Manufacturer Narrative

Investigation pending.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4020559
• MDR Text Key: 19091387
• Report Number: 2027969-2014-00713
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/04/2014

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: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 340746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/04/2014
• Initial Date FDA Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INRATIO MONITOR SN (B)(4); CLONAZEPAM (AS NEEDED); AMBIEN (AS NEEDED); POTASSIUM; COUMADIN
• Patient Outcome(s): Required Intervention