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

Model Number 100071

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2014

Event Type  malfunction  

Event Description

Caller alleged discrepant inratio2 results.Results as follows: time between tests: (b)(6) 2014: 2 hours; (b)(6) 2014: 10 minutes; (b)(6) 2014: 10 minutes.Therapeutic range: 2.5-3.5.Patient self tester is using glucose lancets to obtain blood sample.

Manufacturer Narrative

The customer reported discrepant low inratio inr results during testing.The customer did not provide a reference value for comparison testing for the inratio inr result obtained on (b)(6) 2014.The accuracy of the customer's inratio inr result could not be determined without additional information.It is indicated that product is not returning for evaluation.Therefore, investigation of the complaint to determine root cause cannot be completed.Root cause could not be determined from the information provided by the customer.Since the product associated with the complaint was not returned, retain testing was performed during an in-house investigation.Retain strip testing results met both accuracy and repeatability criteria.The products performed as expected and no product deficiencies were observed.The manufacturing records for the lot were reviewed.The lot met specifications and no non-conformances were documented.No further investigation will be pursued at this time.Based on the information available, there is no indication of a product deficiency.Corrective action is not required at this time.

• Brand Name: INRATIO2 TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3818683
• MDR Text Key: 4451094
• Report Number: 2027969-2014-00307
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• 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: 334472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2014
• 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
• Treatment: COUMADIN, MON, 2.5MG; INRATIO2 METER, SERIAL NUMBER: (B)(4); COUMADIN, TUE-SUN, 5MG; LISINOPRIL