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

Model Number 200432

Device Problem Low Test Results (2458)

Patient Problems Hemorrhage/Bleeding (1888); Test Result (2695)

Event Date 09/08/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inratio inr result in comparison to the laboratory inr result.On (b)(6) 2014, the inratio inr was 2.6 and the laboratory inr was 11.9.The patient's therapeutic range was 2.0 - 3.0.The time between testing was unknown.The patient was hospitalized due to a left groin wound, bleeding of wound and high laboratory inr.During the hospitalization, the patient was administered vitamin ki, coumadin, pain medication and unspecified antibiotics.The patient was discharged from the hospital on (b)(6) 2014.The inratio inr on (b)(6) 2014 was 1.5.Though requested, there was no additional information provided.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

Corrections: 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.Concomitant medical products: removed the monitor as a concomitant medical product and added the inratio pt/inr test strips.510k#: removed the inratio pt/inr test strip 510k# k092987 and added k072727 to reflect the inratio2 pt monitoring system.Investigation/conclusion: the monitor associated with the complaint was returned for investigation.The complaint of a discrepant low result was not replicated when the returned monitor and retain strips were tested using in-house donors.A review of the manufacturing records for the lot did not uncover any non-conformances.This lot met release specifications.Impedance curve analysis was performed on the reported inratio inr results.The impedance curve associated with this case exhibited a weak slope change.Our capa investigation (capa-(b)(4)) has determined that impedance curves with weak slope change can cause discrepant results.The capa investigation has also determined that certain patient conditions (e.G.Low hematocrit, elevated plasma proteins) can contribute to weak slope change impedance curves.The patient has a history of cancer and was hospitalized for a wound in groin at the time for the alleged discrepant result.Capa-(b)(4) has identified cancer as a condition that may contribute to a discrepant inr result.A notification has been sent to customers to inform them of these patient conditions.A possible root cause is the patient condition of cancer which may have contributed to an impedance curve that exhibited weak-slope change.The inratio meter software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak-slope change impedance curve.Further investigation into these issues will be pursued under capa-(b)(4).

• Brand Name: INRATIO2 PT MONITORING SYSTEM
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4274171
• MDR Text Key: 5030416
• Report Number: 2027969-2014-00997
• 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
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/13/2014

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: 350587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Initial Date Manufacturer Received: 01/26/2015
• Initial Date FDA Received: 11/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: COUMADIN; INRATIO MONITOR: SN (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention