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

Model Number 100071

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Anemia (1706)

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.As the patient did not provide a lot number, a manufacturing record review and testing on reserve sample from the same lot could not be performed.Further investigation is not possible at this time.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

In approximately 2009, the patient began using the inratio system to monitor her inr.On or around (b)(6) 2014, the patient experienced aortic valve complications and anemia.The patient alleges the inratio system produced significantly inaccurate inr results which prevented medical providers from prescribing a safe and effective dose of coumadin in a timely manner, resulting in the reported injuries.No additional information was provided.

Manufacturer Narrative

On 01/23/2018, historical records were obtained from alere home monitoring as additional information.

• 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: 6901114
• MDR Text Key: 87652883
• Report Number: 2027969-2017-00150
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 02/14/2018
• 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
• Treatment: INRATIO2 MONITOR, PN AND SERIAL# UNKNOWN
• Patient Outcome(s): Other