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

Model Number 99008G1

Device Problems Incorrect Or Inadequate Test Results (2456); Device Displays Incorrect Message (2591)

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

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

The inratio2 pt/inr test strips 99008g1, lot# k384107 referenced is being reported under a separate medwatch report 2027969-2016-00209.Investigation is pending.

Event Description

On (b)(6) 2016, a physician's office in (b)(6) reported lot to lot variability on the inratio2 testing strips.Results are as follows: date: (b)(6) 2016, inratio2 inr strip lot# k382423: 2.9 and 6.3, inratio2 inr strip lot # k384107: 7.3.The first two (2) attempts, to obtain an inr, on strip lot# k382423 resulted in error messages.Testing was performed consecutively.The therapeutic range was unknown.There was no reported adverse patient sequela and no additional information was able to be provided.(note: this mdr filing is due to the device being the same or similar as a device available in the united states.).

Manufacturer Narrative

Investigation/conclusion: the customer's complaint was not confirmed during in-house testing.In-house testing on strip lots k382423 and k384107 met release criteria and no lot to lot bias was observed.The manufacturing records for the lot were reviewed and the lot met release specifications.A root cause cannot be determined from the information provided.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: INRATIO2 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: 5564029
• MDR Text Key: 42951400
• Report Number: 2027969-2016-00208
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

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: K382423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2016
• 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