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 Problem Chest Pain (1776)

Event Date 04/04/2015

Event Type  malfunction  

Event Description

The caller alleged discrepant high inratio inr results in comparison to the laboratory inr results.The caller was hospitalized for chest pain from (b)(6) 2015.Heparin was administered while hospitalized.This is a normal protocol when patient's are hospitalized, especially for chest pain/angina.Unspecified testing was performed, during the hospitalization, and no clots were found.On (b)(6) 2015, the inratio inr was 2.4 and the laboratory inr was 1.7.The therapeutic range was 2.5 - 3.5.The time between testing was twenty (20) minutes and the testing was performed correctly.On (b)(6) 2015, the inratio inr was 2.7 and the laboratory inr was 1.8.The testing was performed with the same venous sample.Testing with venous blood and while on heparin therapy is considered an off label use.On (b)(6) 2015, the laboratory inr was 2.4 and the caller was discharged from the hospital.There was no reported adverse patient sequela.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing was performed.The retain strip testing results met both accuracy and strip 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.Certain relevant conditions (e.G.Low hematocrit, sepsis) can contribute to discrepant inr results.The patient was reported to have rheumatoid arthritis.Rheumatoid arthritis was identified as a condition that may contribute to a discrepant inr result.A notification letter has been sent to customers to inform them of these patient conditions.Two off-label uses were identified in the complaint.The customer was administered heparin at the time of the discrepancy.Additionally, a venous sample was used to obtain one of the inratio inr results.These cannot be ruled out as possible causes for the unexpected results.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 (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: 4684495
• MDR Text Key: 5671637
• Report Number: 2027969-2015-00267
• 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
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 362568A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 04/13/2015
• 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: UNSPECIFIED OTHER MEDICATIONS; COUMADIN; INRATIO MONITOR (B)(4)