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); Incorrect Or Inadequate Test Results (2456)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is pending.

Event Description

The following was reported via phone call on (b)(6) 2016.Results are as follows: date: (b)(6) 2016, inratio inr: 7.5 and 1.8.Prior week, inratio inr: 0.9.Therapeutic range: 2.0 - 3.0.The time between testing on (b)(6) 2016 was ten (10) minutes.Reportedly, the finger was "milked" after the finger stick, a sufficient blood sample was unable to be obtained and multiple drops of blood was added to the testing strip.These are considered to be improper techniques when performing the inratio test.Additionally, it was possible that the monitor was moved during testing.There was no reported adverse patient sequela and no additional information provided.

Manufacturer Narrative

Investigation/conclusion: as of (b)(6) 2016, the device was not returned for evaluation.Therefore, a review of the testing history for the reported lot was performed.In-house testing on strip lot 370105ar met release criteria and the product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.Although improper techniques were identified in the complaint, the root cause cannot 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.

• 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: 5477558
• MDR Text Key: 39844545
• Report Number: 2027969-2016-00133
• 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,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• 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: 370105AR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2016
• 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