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

Model Number 100071

Device Problem No Apparent Adverse Event (3189)

Patient Problems Coagulation Disorder (1779); Death (1802); Intracranial Hemorrhage (1891)

Event Date 08/09/2016

Event Type  Death  

Manufacturer Narrative

Investigation pending.

Event Description

The patient's wife was prompted to report the death of the patient to alere following receipt of the (b)(6) 2016 medical device recall notification.Below is a summary of the events and inratio inr test results for the patient: patient's therapeutic range: 2.0 - 3.0.Late (b)(6) 2016: the patient experienced an eye bleed (did not seek medical treatment until (b)(6) 2016).On (b)(6) 2016: inratio inr result= 2.5.On (b)(6) 2016: inratio inr result= 2.5.On (b)(6) 2016: inratio inr result= 2.9.On (b)(6) 2016: inratio inr result= 2.5.On (b)(6) 2016: inratio inr result= 2.5.Per the patient's wife, previous inratio inr results provided satisfactory correlation when compared with laboratory test.Previous inratio inr results were not questioned.On (b)(6) 2016: patient visited his optometrist/ophthalmologist for injections to treat the eye bleed reported since (b)(6) 2016.At 5:45pm, the patient became "unresponsive" and "stiff." the patient was immediately transported by helicopter to hospital.At the hospital, the patient was diagnosed with a "massive brain bleed" in the left lobe that was "pushing down on the brain stem." the patient was subsequently placed on a respirator.At 11:05pm, the patient was pronounced dead.A death certificate was obtained for the patient listing the following as the cause of death: intracranial hemorrhage; interval: 6 hours; chronic anticoagulation with supratherapeutic international normalized ratio; interval: unknown.This event is being conservatively reported as a death based on the inability to rule out the possibility that the device may have caused or contributed to the death; however a device deficiency cannot be substantiated at this time.Four days elapsed between the last known inratio inr result and the event [and there are no reported discrepant laboratory inr results].There was no additional information provided.

Manufacturer Narrative

Investigation conclusion: a review of the in-house testing history of strip lot 388422a was performed.In-house testing on the strip lot met release criteria and the product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.Analysis of strip code from returned meter memory corresponded to an alternate lot number.Investigation was unable to confirm the use of the lot number provided by the initial reporter.Additionally, an incorrect date may have been programmed into the meter.Investigation of the returned meter found no indication of product deficiency.The returned meter met functional and thermistor testing requirements.Additionally, impedance curve analysis found that the curves associated with two recent results were normal in shape.The patient was reported to have a condition that may impact the performance of the assay.This could not be ruled out as a cause for the complaint.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• 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 Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5958301
• MDR Text Key: 54994859
• Report Number: 2027969-2016-00624
• 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: consumer
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 388422A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/01/2016
• 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-2354-2016-Z-2362-2016
• Patient Sequence Number: 1
• Treatment: INRATIO 2 PT MONITOR, PN 200432, SERIAL# (B)(4)
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 109