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

Model Number 100139

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Clinical study results were reported to alere by (b)(6) from the (b)(6) study.From (b)(6) 2006 through (b)(6) 2009,a total of 14,264 patients underwent randomization in the study which was terminated on (b)(6) 2010.The study used inratio monitors to measure inr and manage the anticoagulation therapy of patients in the warfarin arm of the study.Inr measurements were intended to be made no less frequently than every 4 weeks for this purpose.At two time points, 12 weeks and 24 weeks, samples for lab inr measurements were collected and were shipped from the more than 1100 clinical sites in 45 countries to a central lab in (b)(4).The patient results provided to alere by (b)(6) included lab inr and inratio inr at both the 12 and 24 week time-points.The time of sampling, time of measurement and other details related to the processing, handling, storage, shipping and testing of the samples were not provided and are unknown.No patient information or medication provided to each patient was provided.The exact date of occurrence for the individual measurements is unknown.(reference: patel et al., new england journal of medical 2011;365:883-91).

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5542944
• MDR Text Key: 42504126
• Report Number: 2027969-2016-00206
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100139
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2016
• 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