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

Model Number 100139

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: lot 050726c was manufactured prior to 2007.A review of the available historical documents did not uncover any information that the lot was notable in its performance.Due to the age of the product, no additional investigation can be performed.Alere has withdrawn the alere inratio®/inratio®2 pt/inr system from the market and is no longer manufacturing alere inratio® test strips and monitors.In addition, all alere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.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

The son of the patient initially called in response to the inratio withdrawal notification.The patient was reported as using the inratio system between 2007 and 2009.During this time, the patient experienced correlation and precision issues on three inratio monitors for two lots of inratio test strips (refer to mdr 2027969-2018-00085 for alternate lot number).The patient's therapeutic range was 2.0-3.0.The patient's inratio inr results varied by 20% (both high and low) as compared to the laboratory.Additionally, the patient would test multiple times in a row on the same monitor and across the other monitors and the inratio inr results would vary.The patient's prescribed warfarin dosage may have been adjusted based on the inratio inr results but the son cannot recall the dosage changes or whether the laboratory inr results influenced these changes.The son of the patient confirmed that no adverse outcomes occurred.The patient discontinued use of the inratio system in 2009.The son of the patient stated that he performed troubleshooting by testing a female non-coumadin user.The son expected to receive an inr of 1.0 but "the results were also all over the place" while using the same three inratio monitors and two lot numbers.

• 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: 7660406
• MDR Text Key: 113457572
• Report Number: 2027969-2018-00086
• 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: other
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100139
• Device Lot Number: 050726C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2018
• 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