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

Model Number 100071

Device Problems Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

Patient Problems No Consequences Or Impact To Patient (2199); Test Result (2695)

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Patient self tester alleging discrepant inratio results (b)(6) 2015 inratio inr = 6.3, repeat inratio inr = >7.5 one minute between tests.Patient's therapeutic range: 2 - 3.Patient self tester historical inratio results: (b)(6) 2015 inratio inr = 3.1.(b)(6) 2015 inratio inr = 2.0.(b)(6) 2015 inratio inr = 2.7.Patient stated no medication changes between (b)(6) 2015 and (b)(6) 2015.No reported adverse patient sequela.No additional information provided.

Manufacturer Narrative

The customer did not provide reference results for comparison.The accuracy of customer's results could not be determined without additional information.It is indicated that product is not returning for evaluation.Since the product associated with the complaint was not returned, the testing history for lot 365429a was reviewed.Retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.The release specification is within the calculated confidence interval of the percent flier rate for complaint investigation testing.A review of the manufacturing records for the lot did not uncover any non-conformances.The lot meets release specification.Customer's technique issue and sample interference cannot be ruled out as a root cause for reported discrepant results.Unable to determine root cause from the information provided by the customer.Based on the information available, there is no indication of a product deficiency.

• 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: 5036865
• MDR Text Key: 25127014
• Report Number: 2027969-2015-00629
• 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
• Report Date: 08/05/2015

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: 365429A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• 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