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 Malaise (2359)

Event Date 06/19/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation/conclusion: it is indicated that 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.The retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.The manufacturing records for the lot were reviewed and the lot met release specifications.The customer reported a history of lupus.Testing with an antiphospholipid antibody syndrome (aps)-insensitive laboratory method is recommended for these patients.The patients sample may have interfered with the coagulation test and may have contributed to the unexpected results.Investigation has determined that certain relevant conditions (e.G.Low hematocrit, sepsis) can contribute to discrepant inr results.The patient was reported to have sjögren's syndrome and an urinary tract infection (uti).Investigation has identified inflammatory conditions and acute infections as conditions that may contribute to a discrepant inr result.Alere technical support discussed the medical device correction letter (december 2014 recall) with patient and emailed a copy of the letter to the patient.Since the monitor was not returned, the impedance curve associated with the discrepant result could not be analyzed.The root cause is unable to be determined at this time without product return.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The caller reported a variance between the inratio inr results and the laboratory inr results.The caller experienced flu symptoms on (b)(6) 2015.On (b)(6) 2015, the inratio inr was 1.3, however, no dose adjustment was made.On (b)(6) 2015, the caller presented to the emergency room due to not feeling well.She was administered 3 liters of saline for dehydration and had a laboratory inr draw performed which was 3.7.Based on the laboratory inr, her coumadin was held.The following day, (b)(6) 2015, she did not test on inratio but took coumadin 2.5 mg which is 1/2 her normal dose.On (b)(6) 2015, she tested on the inratio and received a result of 1.8, which she did not believe and went to the laboratory.The laboratory inr was 3.2.The patient reported having sjogren's syndrome, lupus and a urinary tract infection.There was no additional information provided.

• 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: 4925556
• MDR Text Key: 22497998
• Report Number: 2027969-2015-00524
• 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: Patient
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 360632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2015
• 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
• Patient Outcome(s): Required Intervention