MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT/INR PROFESSIONAL TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 99008G1

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Test Result (2695)

Event Date 06/17/2015

Event Type  malfunction  

Manufacturer Narrative

It is indicated that product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing data was performed.Retain strip testing results met accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.The manufacturing records for the lot were reviewed.The non-conformance associated with this lot was not relevant to the initial complaint and does not affect product performance.Since the product associated with the complaint was not returned, further investigation was not possible.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.No corrective action is required at this time.

Event Description

Customer reported discrepant low results when testing inratio.The results are as follows: inratio2: inr = 1,4, lab method: inr = 2,0.No actual date(s) were provided; the (b)(6) called on the practice and found that no further patient information is available.He also discussed proper handling thoroughly as several handling issues could be identified such as:; incorrect lancets were in use; devices were moved during measurement.(b)(6) indicated the importance of immediately applying the drop of blood on the test strip.

• Brand Name: INRATIO2 PT/INR PROFESSIONAL TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4907375
• MDR Text Key: 22395542
• Report Number: 2027969-2015-00504
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2015

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: Health Professional
• Device Model Number: 99008G1
• Device Lot Number: K362392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/10/2015
• 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