MAUDE Adverse Event Report: ALERE SCARBOROUGH INC. ALERE BINAXNOW INFLUENZA A&B CARD

Model Number 416-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 03/17/2014

Event Type  Death  

Event Description

The patient's symptoms began one week prior to hospital admission.At day of admission, the first alere binaxnow influenza a/b test was performed on nasopharyngeal wash/aspirate and the result was negative.No confirmatory testing was conducted.The second sample was taken on day 12, after the start of symptoms.This second sample, a bronchoalveolar lavage (bal), was run on the alere binaxnow influenza a/b test, and was negative.It is very important to note that bal samples are considered off-label on the alere binaxnow influenza a/b test.Alere does not have data regarding the use of this sample, and performance is unknown.This sample was also run on 2 other non-alere rapid tests, with negative results.Pcr was run on the bal sample, and was positive with a ct value of 27.The patient deceased 13 days after start of the symptoms.Reason of decease was stated to be due to ards (acute respiratory distress syndrome).The customer noted that the ards was caused by mexican flu (h1n1).The analytical reactivity section of the alere binaxnow influenza a/b product insert states that although this test has been shown to detect the flu a/california/04/2009 (h1n1) virus cultured from a positive human specimen, the performance characteristics of this card with human specimens infected with the 2009 h1n1 influenza virus have not been established.The alere binaxnow influenza a and b card can distinguish between influenza a and b viruses, but it does not differentiate seasonal influenza a virus from the novel influenza a (i.E.2009 h1n1) and its ability to detect human infection with the 2009 h1n1 influenza virus in clinical specimens is unknown.

Manufacturer Narrative

According to the alere binaxnow influenza a/b product insert, in the section reporting of results, a negative result should be reported as negative for flu a and flu b protein antigens.Infection due to flu a and flu b cannot be ruled out.Flu a and/or flu b antigen in the sample may be below the detection limit of the test.Alere suggests culture of negative samples.There was no confirmatory testing on the initial sample, as required by the product insert.Additionally, the limitations state that a negative test result does not exclude infection with influenza a and/or b.Therefore, the results obtained with the alere binaxnow influenza a and b card should be used in conjunction with clinical findings to make an accurate diagnosis.The intended use of the test also contains the following statement: caution: assay sensitivity for nasal wash/aspirate samples was determined primarily using archived specimens.Users may wish to establish the sensitivity of these specimens on fresh samples.It is very important to note that bal samples are considered off-label on the alere binaxnow influenza a/b test.Alere does not have data regarding the use of this sample, and performance is unknown.An investigation commenced for alere binaxnow influenza a/b test kit lot 062205.A review of the batch records was conducted, and no abnormalities were noted related to this case.A lot trace was conducted, and no similar cases on this device lot related to false negative results were on record.This device lot consisted of more than (b)(4) devices.Kits retained from the lot were tested, with sensitivity controls for influenza a and b and negative controls.All controls performed as expected.Returned devices were requested (both unused devices and the device in question), and were unavailable.The remaining patient sample was unavailable as well.

• Brand Name: ALERE BINAXNOW INFLUENZA A&B CARD
• Type of Device: ALERE BINAXNOW INFLUENZA A&B CARD
• Manufacturer (Section D): ALERE SCARBOROUGH INC.; 10 southgate rd.; scarborough ME 04106
• Manufacturer Contact: 10 southgate rd.; scarborough, ME 04106 ; 2077305809
• MDR Report Key: 3775359
• MDR Text Key: 4373739
• Report Number: 1221359-2014-00001
• Device Sequence Number: 1
• Product Code: GNX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K053126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 416-000
• Device Catalogue Number: 416-000
• Device Lot Number: 062205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: WITH PCR; TWO OTHER RAPID TESTS WERE RUN (NEGATIVE), ALONG
• Patient Outcome(s): Death
• Patient Age: 39 YR
• Patient Weight: 89