MAUDE Adverse Event Report: ALERE SAN DIEGO INRATIO; PROTHROMBIN TIME TEST

Model Number 100139

Device Problem Imprecision (1307)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2013

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide comparison inr values for the tests performed on (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013.Unable to determine the accuracy of the customer's reported inr results without this info.The customer did not provide lot numbers or return products for investigation.Manufacturing record review was not performed because a lot number was not provided.Since the product associated with the complaint was not returned and a lot number was not provided, further investigation was not possible without add'l info.Root cause could not be determined from the info provided by the customer.Results of the query of similar incidents in the complaint system for this trend code did not indicate a manufacturing issue.This issue will be subject to future tracking and trending.No corrective action required at this time as no product deficiency was established.

Event Description

"customer alleged correlation issue with inratio meter and lab.Results as follows:" (b)(6) 2013 inr 3.0 finger stick, (b)(6) 2013 inr 5.1 venous, (b)(6) 2013 inr 5.1 venous, (b)(6) 2013 inr 3.3 venous, (b)(6) 2013 inr 2.8 venous, (b)(6) 2013 inr 3.4 finger stick, (b)(6) 2013 inr 2.7 finger stick, (b)(6) 2013 inr 10.2 venous, (b)(6) 2013 inr 3.3 finger stick, (b)(6) 2013 inr 7.7 venous.Unk time between the tests performed on the same days.Correlation was for one pt using two to three lots (no lot numbers provided) and one meter.No therapeutic range provided.

• Brand Name: INRATIO
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3736435
• MDR Text Key: 19398347
• Report Number: 2027969-2014-00078
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2014

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: 100139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 01/31/2014
• 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