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

Model Number 100071

Device Problems Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456)

Patient Problems Anemia (1706); Sepsis (2067); Urinary Tract Infection (2120)

Event Date 07/25/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

The caller alleged a variance between the inratio inr result and the laboratory inr result.On (b)(6) 2015, the patient tested on the inratio and the inr result was 1.7.Multiple drops of blood was added to the testing strip.This is considered to be an improper technique when testing on the inratio device.The patient's therapeutic range was 2.0 - 3.0, therefore the patient's spouse recommended to increase the coumadin for the day to 3mg.The patient's normal coumadin dose was 1-2 mg daily.Two (2) days later on (b)(6) 2015, the patient was scheduled to be hospitalized and have a planned kidney stone procedure.Upon admission to the hospital, the laboratory inr was 8.0 and the patient was diagnosed as having severe sepsis and anemia.During the hospital stay, the patient was taken off coumadin, the kidney stones were removed and the patient was given 3 pints of blood.On (b)(6) 2015, the patient was discharged from the hospital in stable condition.His hematocrit was 27.6 and the inr was 1.18.As of (b)(6) 2015, the patient was bridging onto coumadin with lovenox.The caller indicated that over the past two (2) years that the patient had been dealing with chronic kidney stones and urinary tract infections which often resulted in sepsis.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: as of 10/14/2015, the product was not returned for evaluation.A review in-house testing was performed.The in-house strip testing on strip lot 364994a met criteria and the product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.There is no indication of a product deficiency and corrective actions are required.Capa investigation (capa-14-005) has determined that certain relevant conditions (e.G.Low hematocrit, sepsis) can contribute to discrepant inr results.The patient was reported to have severe sepsis and anemia.This capa has identified these conditions as a conditions that may contribute to a discrepant inr result.Since the monitor was not returned, the impedance curve associated with the discrepant result could not be analyzed for characteristics of a weak-slope change.An impedance curve with a weak-slope change has also been identified in capa-14-005 to contribute to a potential discrepant result.Although an improper technique was identified in the complaint, a root cause could not be determined from the information provided by the customer.Further investigation was performed under capa-14-005.

• 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 (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: 5042858
• MDR Text Key: 24655221
• Report Number: 2027969-2015-00636
• 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
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• 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: 364994A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2015
• 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-0880-0881-0882-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention