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

Model Number 200432

Device Problems Incorrect Or Inadequate Test Results (2456); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); Test Result (2695)

Event Date 04/16/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio value: patient's therapeutic range 3 - 4: on (b)(6) 2016: inratio=1.7, lab=6.4 lab draw performed within an hour of testing on inratio meter; after receiving lab result of 6.4, physician instructed patient to hold warfarin (b)(6) 2016.Patient's historical results: on (b)(6) 2016 inratio=2.8, dosage was increased but patient unable to provide exact amount; on (b)(6) 2016 inratio=2.1, increased to 10 mg tuesday night, 7 mg on wednesday and thursday; on (b)(6) 2016 inratio=1.4.

Manufacturer Narrative

The meter associated with the complaint was returned for investigation.Retain strip investigation was not performed on the returned meter due to the recovered impedance curve associated with the customer's reported inr result of 1.7 being identified as having 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).Functional and thermistor testing were performed on the returned meter with passing results.A review of the entire testing history for lot 370105ar was performed.In-house testing for this lot meets criteria.No product deficiency was found for the lot.A review of the manufacturing batch records for the reported lot did not uncover any relevant non-conformances; the lot met release specifications.The capa investigation has also determined that certain patient conditions can contribute to weak slope change impedance curves.It was reported that the patient has lupus.This is a condition which may impact the performance of the assay and cannot be ruled out as the cause of the unexpected result observed by the customer.(b)(4) identified impedance curves with weak slopes and abnormal shapes as potentially leading to discrepant inr values.Further investigation is being performed under (b)(4) for this issue.Brand name: 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: 5651611
• MDR Text Key: 45097286
• Report Number: 2027969-2016-00312
• 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
• Report Date: 04/16/2016

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: 200432
• Device Lot Number: 370105AR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2016
• 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
• Patient Outcome(s): Required Intervention