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

Model Number 99008G1

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 Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

A variance between inratio inr results was reported in (b)(6).The results were as follows: 1.2 and 2.1 with the same patient on the same day; exact date unknown; therapeutic range unknown.It was reported that the monitor had been moved during testing, the wrong lancet size was used and the finger stick was performed too early.No further information is available.(note: the inratio2 product 99008g1 is not available in the united states; however, this mdr filing is due to a same or similar device being available in the united states.).

Manufacturer Narrative

It is indicated that the product is not returning for evaluation.Since the product associated with the complaint was not returned, in-house testing was performed on the reported lot number.The customer's complaint was not confirmed during in-house testing.In-house testing on the reported strip lot met expectations.The product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.Improper techniques and user issues 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: INRATIO2 PT/INR 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: 5807409
• MDR Text Key: 50818962
• Report Number: 2027969-2016-00523
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• 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: K386714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2016
• 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