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 Problem Hematuria (2558)

Event Date 06/17/2015

Event Type  Injury  

Event Description

Caller alleging discrepant inratio value patient's therapeutic range 2.5 - 3.5 (b)(6) 2015 inratio = 3.5; lab = 6.9 time between tests > 4 hours but < 5 hours.(b)(6) 2015 inratio = 3.4; lab = 5.9 time between tests < 10 minutes.Patient self tester went to the er at the hospital on (b)(6) 2015 after seeing blood in his urine.Patient was discharged the same day as the md's concluded the blood in the urine was due to his increased inr reading obtained through their lab.Patient stated that the doctors at the hospital er advised him to hold his warfarin for (b)(6) 2015 and (b)(6) 2015.Patient resumed on 2 mg of warfarin from (b)(6)2015 -(b)(6)2015 and is currently on 3 mg daily, starting on (b)(6) 2015.Inr of 2.3 obtained through the lab on (b)(6) 2015.No inratio test has been performed since (b)(6) 2015.No additional information provided.

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.Since the products associated with the complaint was not returned, a review of in-house testing data was performed.Retain strip testing results met 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 non-conformances.The lot meets release specification.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.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: 4910666
• MDR Text Key: 6055882
• Report Number: 2027969-2015-00510
• 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: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• 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: 365429A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2015
• 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: TRIAMTERENE; LORATIDINE; INRATIO ONITOR SERIAL #(B)(4); VITAMIN D; METROPOLOL; LOVASTATIN; WARFARIN
• Patient Outcome(s): Required Intervention