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

Model Number 99007G1

Device Problems Low Test Results (2458); Missing Test Results (3267)

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

Event Date 04/02/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation is pending.

Event Description

A patient (end user) in (b)(6) reported that his inratio monitor had adhesive residue on the strip guide and that he had five (5) low inratio2 inr results in comparison to the laboratory inr results since (b)(6) 2015.Results are as follows: (b)(6).Therapeutic range: not provided it is unknown if all the results were from the same inratio strip lot; however, the last two (2) results were from inratio strip lot # k374966.There was no reported adverse patient sequela and no additional information was 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

Correction to suspect medical device model #.Correct model # is 99007g1.Investigation/conclusion: the monitor associated with the complaint was returned for investigation; however, no testing strips were returned.Functional and thermistor testing were performed on the returned monitor with passing results.The customer's complaint was not confirmed during in-house testing.Retain and returned strips tested on the returned monitor met accuracy criteria.Impedance curve analysis could not be performed because the customer's reported inratio inr results were not within the last four results saved in the monitor memory.The manufacturing records for the lot were reviewed and the lot met release specifications.A 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 and no corrective action is required.

Manufacturer Narrative

(b)(4).Correction: the monitor was returned, however, the test strips were not returned.Therefore, replace statement, "retain and returned strips tested on the returned monitor met accuracy criteria" with "retain strips tested on the returned monitor met accuracy criteria.".

• 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: 5392029
• MDR Text Key: 37032018
• Report Number: 2027969-2016-00048
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2016

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: Lay User/Patient
• Device Model Number: 99007G1
• Device Lot Number: K374966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/26/2016; 06/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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