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

Model Number 100071

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Hemoptysis (1887); Swelling (2091)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

Caller alleged discrepant inratio results.Results as follows: date: (b)(6); inratio error: 1.6; nurse's poc: 3.0 (minutes between tests).Patient tried taking her inr home on her inratio monitor and obtained an unspecified error.Her legs were swollen and she was coughing up blood, so she went to the hospital.The hospital took 3 blood samples to test her inr and were unable to obtain a reading.Patient was given 4 bags of plasma and was transferred to (b)(6) hospital.While being transferred she was given another bag of plasma.The patient arrived at (b)(6) hospital in the evening and they were able to obtain an inr of 3.2.She was admitted to the hospital (b)(6) and was released (b)(6).The first hospital believed the patient had coumadin toxicity, and this is why they were unable to obtain an inr reading.Prior to (b)(6), the patient stated that she was getting inr values that were 1.X.She also stated that she noticed when she was on the antibiotic therapy for uti (dates (b)(6)) that her inr was decreasing.Her physician waited until she was done with the antibiotic therapy to increase her dosage of coumadin from 3mg to 9mg.

Manufacturer Narrative

Pending investigation.

• 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: 3901936
• MDR Text Key: 4650274
• Report Number: 2027969-2014-00405
• 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: 04/10/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 334474
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2014
• Initial Date FDA Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: No
• 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: AMITRIPTYLINE (03/15/14-03/21/14); HYDROCODONE (03/15/14-03/21/14); ANTIBIOTICS (03/15/14-03/21/14); COUMADIN (03/15/14-03/21/14); METOPROLOL (03/15/14-03/21/14); INRATIO MONITOR, SERIAL NUMBER: (B)(4)