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

Model Number 99007EU

Device Problems Incorrect Or Inadequate Test Results (2456); Appropriate Term/Code Not Available (3191)

Patient Problem Coagulation Disorder (1779)

Event Date 11/27/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: further investigation to determine whether the product failed to meet specifications cannot be pursued because the customer did not return the product and did not provide a lot number.The root cause cannot be determined due to insufficient information.No corrective action is required.

Event Description

While testing using the inratio system, the patient reportedly suffered from an eye stroke in (b)(6) 2016.The patient alleges that inaccurate inratio inr results may have caused the eye stroke event.

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history of the lot was performed.The complaint lot 385941 expired prior to alere obtaining the complaint; in-house testing of the device lot was not possible.However, device lots 385940 and 385942, which originate from the same brick lot as the complaint lot, were previously tested in-house.In-house testing of these strip lots met release criteria.The product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.Additional information was provided in a letter received september 12, 2017.This letter included the lot number of the test strips used.The mdr has been updated to reflect the new information and the updated investigation using the lot number provided.(report type) has been updated to reflect this report is only being filed as a serious injury.The additional information received does not evidence a reportable variance or a malfunction of the device.(date of event) updated to reflect event date of as (b)(6) 2016.(date of this report) updated to reflect date of information contained in letter as 09/12/2017.(suspect medical device) have been updated to reflect new information provided.(premarket identification) updated to reflect appropriate 510k of k110212.(labeled for single use) updated to yes to reflect new information.(event problem and evaluation codes) updated to reflect findings of current investigation.

Event Description

Additional information was provided in a letter received september 12, 2017: the patient began using the inratio system in 2009.On (b)(6) 2016, the patient suffered a massive left eyeball effusion with a diagnosis of a subconjunctival hemorrhage.The patient then went to the hospital where he was prescribed anti-coagulants.On (b)(6) 2016, the patient tested using the inratio system and received an inr result of 5.4.The patient subsequently stopped taking the prescribed anti-coagulants.When the patient attempted to obtain additional test strips, the patient was informed of the inratio system withdrawal.The patient then decided to purchase a roche system to monitor his inr.On (b)(6) 2016, the patient received an inr result of 3.1 using the roche system.The patient's eye eventually returned to normal but the hemorrhage left a permanent cosmetic defect.Original event description: while testing using the inratio system, the patient reportedly suffered from an eye stroke in (b)(6) 2016.The patient alleges that inaccurate inratio inr results may have caused the eye stroke event.

• Brand Name: INRATIO 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 Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6715683
• MDR Text Key: 80122873
• Report Number: 2027969-2017-00113
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 99007EU
• Device Lot Number: 385941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2017
• 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
• Removal/Correction Number: Z-2354, 2362-2016
• Patient Sequence Number: 1
• Patient Outcome(s): Other