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

Model Number 100071

Device Problems Improper or Incorrect Procedure or Method (2017); High Test Results (2457)

Patient Problems Thrombus (2101); Complaint, Ill-Defined (2331)

Event Date 12/01/2014

Event Type  Injury  

Event Description

Physician called on behalf of patient alleging discrepant high inratio value.On (b)(6) 2014, patient self tester inratio 3.6.Patient awoke on (b)(6) 2014 with heart attack like symptoms, went to emergency department and was admitted to hospital, lab inr result was 1.2.Patient diagnosed with blood clot in left atrium that moved to coronary artery - clot removed by suction (embolectomy).Three days between initial inratio reading and hospital lab inr.In reviewing techniques, patient self tester admitted applying in wrong mode, touching strip on (b)(6) 2014.On (b)(6) 2014, inratio 2.1; on (b)(6) 2014, inratio 2.9.Again, improper techniques were addressed, patient self tester not waiting for green light and touching strip.Patient's therapeutic range 2.5 - 4.0.Additional hospitalization and patient information was requested but not provided or available.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

Investigation/conclusion product was returned for investigation.The complaint was not confirmed.Retain strip testing with returned meter met both accuracy and strip repeatability criteria.The product performed as expected and no product deficiencies were observed.Investigation of the returned meter did not uncover any deficiencies.The meter continues to meet specification.A review of the manufacturer record for the lot did not uncover any relevant non-conformance.Lot meets release specification.Root cause is unable to be determined from the information provided.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

Investigation/conclusion update: although user issues and technique issues were identified in the complaint, a root cause could not determined 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
• MDR Report Key: 4400110
• MDR Text Key: 22159436
• Report Number: 2027969-2015-00010
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2014

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 01/08/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/10/2015; 03/13/2015
• 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
• Treatment: INRATIO MONITOR SERIAL #(B)(4); WARFARIN
• Patient Outcome(s): Hospitalization; Required Intervention