MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-04-15 for ALERE BINAXNOW INFLUENZA A&B CARD 416-000 manufactured by Alere Scarborough Inc..
[4373739]
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.
Patient Sequence No: 1, Text Type: D, B5
[11772297]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221359-2014-00001 |
| MDR Report Key | 3775359 |
| Report Source | 01 |
| Date Received | 2014-04-15 |
| Date of Report | 2014-04-15 |
| Date of Event | 2014-03-17 |
| Date Mfgr Received | 2014-03-17 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2014-04-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 10 SOUTHGATE RD. |
| Manufacturer City | SCARBOROUGH ME 04106 |
| Manufacturer Country | US |
| Manufacturer Postal | 04106 |
| Manufacturer Phone | 2077305809 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALERE BINAXNOW INFLUENZA A&B CARD |
| Generic Name | ALERE BINAXNOW INFLUENZA A&B CARD |
| Product Code | GNX |
| Date Received | 2014-04-15 |
| Model Number | 416-000 |
| Catalog Number | 416-000 |
| Lot Number | 062205 |
| Device Expiration Date | 2015-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SCARBOROUGH INC. |
| Manufacturer Address | 10 SOUTHGATE RD. SCARBOROUGH ME 04106 US 04106 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-04-15 |