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

Model Number 100071

Device Problems Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017); Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2015

Event Type  malfunction  

Event Description

Caller alleging discrepant low inratio values.(b)(6) 2015: inratio: 1.2; lab: 2.6.One hour between tests.Patient self tester stated being off coumadin for five days prior to endoscopy on (b)(6) 2015.Resumed coumadin on (b)(6) 2015.(b)(6) 2015: inratio: 1.1.Patient's therapeutic range: 2-3.Patient not having meter in correct mode when fingerstick was performed.Patient self tester had meter on lap during test; also reported milking finger after fingerstick.No reported adverse patient sequela.No additional information provided.

Manufacturer Narrative

Investigation conclusion: the customer reported discrepant low inratio inr results during testing.It is indicated that the product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing data was performed.Retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.A review of the manufacturing records for the lot did not uncover any relevant non-conformances.Lot meets release specification.Technique issue was identified in the complaint.This could not be ruled out as a possible cause of the unexpected results.In addition, the meter was on customer's lap during test.This can disrupt sample flow/migration and contribute to unexpected inr results.This may have contributed to the unexpected results observed by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• 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: 4748956
• MDR Text Key: 5827001
• Report Number: 2027969-2015-00324
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• 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: 360632
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2015
• 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: COUMADIN; INRATIO MONITOR SERIAL #(B)(4)