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

Model Number 200432

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); Sepsis (2067)

Event Date 12/16/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

The customer's (end user's) spouse called alere home monitoring (distributor) to discontinue use of the inratio monitor.During the call, it was discovered that the consumer was requesting to be removed for their services due to a discrepancy.The following information was received from the distributor, the spouse and the customer: the customer was previously hospitalized for 45 days due to sepsis and was placed on an unspecified type of antibiotic.Following the hospitalization, the customer was place in a rehabilitation facility for two weeks and discharged on (b)(6) 2015.Spouse states that the customer was generally obtaining results within her therapeutic range of 2.0 - 3.0 between the dates of (b)(6) 2016 and (b)(6) 2015, some results may have been outside of the range but nothing alarming.The customer was on and off antibiotics during that time frame.On (b)(6) 2016, the customer tested on the inratio device and received an inr of 3.5.Due to blood in the customer's stool, she was taken to the hospital where her laboratory inr was 19.9.The hospital result was retested as spouse did not believe the result due to obtaining the 3.5 on the monitor an hour prior.The spouse stated that he also noticed that the customer was bruising easily and there was occasional bleeding prior to (b)(6) 2015.The customer was hospitalized and transfused with 8 units of plasma and 1 pint of blood, spouse was not sure if any additional treatment was provided.The customer was discharged from the hospital 7 days later.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: the monitor associated with the complaint was returned for investigation.There were no testing strips returned.A review of the testing history for strip lot 365984a was performed.In-house testing for this lot met criteria and no product deficiency was established.The manufacturing records for the lot were reviewed and the lot met release specifications.Retain strip investigation was not performed on the returned monitor due to the recovered impedance curve associated with the customer's reported inratio inr result of 3.5.This impedance curve was statistically analyzed and determined to exhibit a weak-slope change.This issue is related to the algorithm software on the monitor and was addressed in capa-(b)(4).The inratio monitor software may generate an incorrect or discrepant inr result with patient samples exhibiting a weak-slope change impedance curve.The capa investigation has also determined that certain patient conditions can contribute to weak slope change impedance curves.The patient had a recent history of sepsis and was known to be discontinuously taking antibiotics.Sepsis is a condition which may impact the performance of the assay.Functional and thermistor testing were performed on the returned monitor with passing results.Further investigation was performed under capa-(b)(4).

• 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 (Section G): 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: 5393689
• MDR Text Key: 36905838
• Report Number: 2027969-2016-00050
• 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,distributor,other
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 200432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2016
• 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
• Treatment: OTHER UNSPECIFIED MEDICATIONS
• Patient Outcome(s): Hospitalization; Required Intervention