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); Low Test Results (2458)

Patient Problems Chest Pain (1776); Anxiety (2328)

Event Date 03/12/2015

Event Type  malfunction  

Event Description

On 03/26/2015, a phone call was received from the customer alleging unexpected low inratio inr results.The customer was hospitalized, for one night, in late (b)(6) for chest pain which was diagnosed as a panic attack and not related to the inratio device.At the time of hospitalization, the customer's laboratory inr was 2.5 which was in the therapeutic range of 2.5 - 3.5.The customer was not concerned with that result.For the next three (3) weeks ((b)(6) 2015) the inratio inr was 1.9.The customer reported that the finger was "milked", multiple drops of blood was added to the test strip and the finger was touched to the sample well.These are considered improper techniques.There was no reference laboratory comparison performed during this time.On (b)(6) 2015, the inratio inr was 2.8 and the laboratory inr was 2.6.There was no reported adverse sequela.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: the customer reported unexpected discrepant low results during testing.It is indicated that the product is not returning for evaluation.Therefore, an investigation of the complaint to determine root cause cannot be completed.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 non-conformances and the lot met release specification.Although the root cause analysis did not include return testing, improper techniques were identified in the complaint.These could not be ruled out as a cause of 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: 4648234
• MDR Text Key: 5595734
• Report Number: 2027969-2015-00240
• 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
• Type of Report: Initial
• Report Date: 03/26/2015

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: 362393A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 04/01/2015
• 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)