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

Model Number 100071

Device Problem High Test Results (2457)

Patient Problems Stroke/CVA (1770); Twitching (2172); Brain Injury (2219)

Event Date 02/10/2015

Event Type  Injury  

Event Description

On 03/23/2015, a phone call was received from a customer alleging discrepant high inratio inr results in comparison to the laboratory inr results.The following is a chronological order of available information.The customer reports result to physician who adjusts the coumadin based on the specific result.Therapeutic range: 2.0 - 3.0; coumadin 8mg daily; (b)(6) 2015: inratio=3.3; (b)(6) 2015: inratio=3.9; coumadin changed from 8mg daily to 3-4mg daily alternating doses.(b)(6) 2015: inratio=3.1; coumadin changed from alternating doses of 3-4mg to 4mg daily.(b)(6) 2015: inratio=1.3 customer reported result to physician and believes the dose was increased to 8mg daily; however, the customer could not recall.(b)(6) 2015: the customer was hospitalized after experiencing a stroke at 4:00am.The customer had progressive twitching on his left hand side and went to the hospital.The laboratory inr was 1.1.Intravenous (iv) heparin was administered from (b)(6) 2015 - (b)(6) 2015.Keppra and decadron were started the week of (b)(6) 2015.(b)(6) 2015: the customer was discharged to a rehabilitation facility.Customer states that there is permanent brain damage but was unwilling to provide details.Therapeutic range changed to 2.5 - 3.5.Coumadin was restarted after discharge at 10mg daily.(b)(6) 2015: inratio=2.9; lab=2.5 (different strip lot number but customer was not able to provide specific lot number).(b)(6) 2015: inratio=2.9; lab=2.5 (different strip lot number but customer was not able to provide specific lot number).(b)(6) 2015: inratio=3.8; lab=3.1 coumadin 10mg daily.(b)(6) 2015: inratio=5.1; lab=3.5 coumadin changed to 8mg daily.Each laboratory draw was performed within one (1) hour of inratio test.The customer was expected to be discharged from the rehabilitation facility by (b)(6) 2015; however, as of (b)(6) 2015, the customer remained in the facility.(b)(6) 2015: inratio=3.0 and lab=2.6 customer was testing with new supplies and monitor.He was upset with results and unwilling to troubleshoot, provide strip lot number or serial number of monitor.Customer reported recent diagnosis of lupus.There was no additional information provided.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

Investigation/conclusion: as of 05/19/2015, the product has not returned 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.A review of the manufacturing records for the lot did not uncover any relevant non-conformances and the lot met release specification.A root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency and no corrective action is required at this time.If the device is returned, an evaluation will be performed and a supplemental report will be submitted.

Manufacturer Narrative

It was reported that the customer was recently diagnosed with lupus.Testing with an antiphospholipid syndrome (aps)-insensitive laboratory method is recommended for these patients.The customer's blood sample may have interfered with the coagulation test and may have contributed to the unexpected results.

• 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: 4697678
• MDR Text Key: 15960602
• Report Number: 2027969-2015-00282
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2015

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: 06/24/2015
• Initial Date FDA Received: 04/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/27/2015; 06/26/2015
• 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: INRATIO MONITOR: SN (B)(4); COUMADIN
• Patient Outcome(s): Hospitalization; Required Intervention