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 Hematuria (2558); Test Result (2695)

Event Date 01/02/2016

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

The caller (end user) alleged a variance between the inratio inr result and an alternate point of care (poc) inr result.The following information was provided.The end user explained that she normally alternates coumadin 7.5mg and 10mg daily and takes the dose at 9:00pm and her therapeutic range is 2.0 - 3.0.Additionally when she tests on the inratio device, she stated that she ties a rubber band around her finger prior to performing all her inratio tests.On (b)(6) 2016, she took coumadin 7.5 mg which was her normal dose for that day.On (b)(6) 2016, the inratio inr was 1.2.She took coumadin 10mg, per physician order.On (b)(6) 2016, the caller took coumadin 10mg, per physician order.On (b)(6) 2016, the caller had a doctor's appointment and an alternate poc inr was 8.0.There was no inratio test performed on that day.Due to blood in her urine and an elevated inr, she was sent to the emergency room.The laboratory inr was 8.0 and she was administered oral vitamin k.On (b)(6) 2016, at the caller's doctor's appointment the alternate poc inr was 5.1 and the inratio inr was 4.6.The time between the two tests was 10 minutes.Coumadin was held for the day.On (b)(6) 2016, at the caller's doctor's appointment the alternate poc inr was 2.9 and she took coumadin 5mg, per physician order.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: as of 02/25/2016, the product was not returned for evaluation.Therefore, a review of the in-house testing history of the lot was performed.In-house testing on the reported strip lot met release criteria and the product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.The patient's normal coumadin dose was alternating 7.5mg and 10mg.On (b)(6) 2016, the patient took the normal 7.5mg dose and on (b)(6) 2016 after the inratio inr result of 1.2 the normal 10mg dose was taken.On (b)(6) 2016, a 10mg dose of coumadin was taken instead of the normal 7.5mg.Starting, stopping, or changing the dose can affect the inr value.This may have contributed to the difference between the results obtained on (b)(6) 2016.An improper technique was identified in the complaint.This cannot be ruled out as a root cause to customer's unexpected results.A root cause could not be determined from the information provided by the customer.Further investigation under (b)(4) which was initiated to investigate highly discrepant results.

Event Description

On (b)(6) 2016, the laboratory inr result was 8.0.

• 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 (Section G): 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: 5394811
• MDR Text Key: 36954837
• Report Number: 2027969-2016-00051
• 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: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• 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: 367839A
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention