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

Model Number 100071

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Death (1802); Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

Information was received regarding the death of a patient due to blood loss and resulting trauma.Information alleged "dangerously high inr anticoagulant levels" while using the inratio system; however, there is no information directly linking the patient's death to use of the inratio system.No medical records, death certificate or identifying product information (e.G.Serial number) was provided.It is indicated that the product is not returning for evaluation.Additionally, a lot number of the test strip product was not provided and neither manufacturing record review nor testing on reserve sample from the same lot could be performed.Further investigation is not possible at this time.Alere has withdrawn the alere inratio®/inratio®2 pt/inr system from the market and is no longer manufacturing alere inratio® test strips and monitors.In addition, all alere inratio® test strips are now expired.Customers have been advised to work with their healthcare provider to transition to an alternative monitoring method, such as a plasma-based laboratory inr method or a point-of-care monitoring system from a different manufacturer.

Event Description

On 11/8/18, abbott legal received a legal complaint from outside counsel regarding the alere inratio 2 monitoring system, and forwarded the legal complaint document to alere (b)(4) technical services (asd ts) for review of alleged product complaint.The legal complaint document includes the following information: "deceased used the alere inratio 2 monitoring system from approximately 2002 until (b)(6) 2016.During this time period, deceased utilized the alere inratio 2 monitoring system as intended and directed.More specifically, deceased would prick her finger with the machine and then place her blood on the strips.She would then feed the strips into the alere inratio 2 monitoring system, wait for and read the test results, and would then contact her own doctor with the results.Based on the results provided, the doctor would increase or lower her dose of coumadin.At all times material hereto, deceased used the alere inratio 2 monitoring system appropriately, as directed and consistent with all instructions provided to her.Despite using the alere inratio 2 monitoring system as intended and directed, and without knowledge of the dangers of the alere inratio 2 monitoring system, plaintiff began developing symptoms consistent with dangerously high inr anticoagulant levels.Her symptoms included but were not limited to blood loss, anemia, internal bleeding and unresponsiveness.Despite using the alere inratio 2 monitoring system as intended and directed, these perilous symptoms persisted, resulting in hospitalization, admission to a nursing home and ultimately her death.On (b)(6) 2016, deceased passed away from complications associated with her blood loss and resulting trauma to her body." per abbott legal, no further information, including medical records, is currently available.

Manufacturer Narrative

It is indicated that the product was not returning for evaluation.In-house testing of retention product for lot 389535a performed on 8/13/2019 had no failures and the results met expectations.The product performed as expected.A review of the manufacturing records for lot 389535a did not uncover any non-conformances.The lot met release specifications.The customer did not provide a comparative for the reported inratio values.It is not possible to verify if a discrepancy exists without this information.Alere has withdrawn the alere inratio®/inratio®2 pt/inr system from the market and is no longer manufacturing alere inratio® test strips and monitors.In addition, all alere inratio® test strips are now expired.Please work with your healthcare provider to transition to an alternative monitoring method, such as a plasma-based laboratory inr method or a point-of-care monitoring system from a different manufacturer.

• Brand Name: INRATIO 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
• MDR Report Key: 8131740
• MDR Text Key: 129302654
• Report Number: 2027969-2018-00160
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2017
• Device Model Number: 100071
• Device Lot Number: 389535A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2354, 2362-2016
• Patient Sequence Number: 1
• Treatment: WARFARIN; WARFARIN
• Patient Outcome(s): Death