MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT MONITORING SYSTEM; PROTHROMBIN TIME TEST

Model Number 200432

Device Problems Device Issue (2379); Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

Patient Problems Hemorrhage/Bleeding (1888); No Consequences Or Impact To Patient (2199)

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio values.(b)(6).

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.In-house testing on strip lot 373678a was found to be performing within expectations.A review of the manufacturing records for the lot did not uncover any non-conformances.The lot meets release specification.The customer did not provide a laboratory reference value for comparison.Unable to determine the accuracy of the inratio result without this information.Root cause cannot be determined from the information provided.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

Investigation/conclusion: the meter associated with the complaint was returned for investigation.In-house testing on retained test strips met accuracy criteria.Functional and thermistor testing were performed on the returned meter with passing results.The customer's reported issue was not replicated during in-house investigation.The product performed as expected.A review of the entire in-house testing history of the lot was performed.In-house testing on the reported strip lot met release criteria.The product performed as expected.A review of the manufacturing records for the lot did not uncover any non-conformances.The lot met release specifications.The customer did not provide a reference value for comparison.It is not possible to verify if a discrepancy exists without this information.Root cause cannot be determined from the information provided.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

The meter associated with the complaint was returned for investigation.In-house testing on retained test strips met accuracy criteria.Functional and thermistor testing were performed on the returned meter with passing results.The customer's reported issue was not replicated during in-house investigation.The product performed as expected.A statistical analysis of the impedance curves generated using the customer's reported inratio inr results determined that the curves associate with the reported result of 6.0 on (b)(6) 2016 and historic result of 7.0 on (b)(6) 2016 did not exhibit a weak or abnormal slope.However, the result of 6.0 obtained on (b)(6) 2016 was found to exhibit a weak slope change.The issue of weak-slope changes is related to the algorithm software on the meter and is known to contribute to discrepant results.This issue was addressed in (b)(4).With the exception of the weak-slope observed on the customer's returned meter, in-house testing shows that the system is performing within expectations.A review of the entire in-house testing history of the lot was performed.In-house testing on the reported strip lot met release criteria.The product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.The customer did not provide a reference value for comparison.It is not possible to verify if a discrepancy exists without this information.Root cause cannot be determined from the information provided.(b)(4) identified impedance curves with weak slopes as potentially leading to discrepant inr values.Further investigation is being performed under (b)(4) for this issue.Corrections: removed inratio pt/inr test strips (as the complaint device) and added the inratio2 pt monitoring system (monitor).Model #: removed inratio pt/inr test strip and added the monitor model 200432.Lot#: removed inratio pt/inr test strip lot number and included serial number of monitor as above.Removed the monitor as a concomitant medical product and added the inratio pt/inr test strips.The 510k#: removed the inratio pt/inr test strip 510k# k092987 and added k072727 to reflect the inratio2 pt monitoring system.Labeled for single use?: changed from "yes" to "no" since the monitor is not a single use device.Usage of device: changed from "unknown" to "reuse" since the monitor is not a single use device.

• Brand Name: INRATIO2 PT MONITORING SYSTEM
• 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: 5514808
• MDR Text Key: 41137182
• Report Number: 2027969-2016-00182
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/24/2016

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: 200432
• Device Lot Number: 373678A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/23/2016; 06/28/2016; 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1