MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-01 for ALERE BINAXNOW LEGIONELLA URINARY ANTIGEN TEST 852-100 manufactured by Alere Scarborough Inc..
[137670117]
Testing was performed at alere (b)(4) on retained kit lot e07293 with positive and negative urine control samples. All test results were valid and performed as expected. Additionally, the manufacturing batch records for lot e07293 were reviewed. This lot met the required release specifications. A review of the complaints reported as false positive or unconfirmed false positive related to lot number e07293 showed that the complaint rate is (b)(4). The evidence available does not indicate that the product is performing outside label claims. Alere scarborough was unable to determine the exact root cause of the reported issue. The decision to report this event represents a very conservative approach. While we lack sufficient information to exclude the possibility that the "false positive" caused or contributed to the death in this case, many other factors in this case are much more likely to have contributed to the patient's death: age: mortality rate of pneumonia among elder patients (>65 years) is very high (~12%). Severity: patient was in a severe condition (in itu) and mortality rate of pneumonia greatly depends on the clinical setting where it is treated: 5-10% mortality rate in inpatients not requiring icu care, as high as 25% in intubated patients, and nearly 50% in icu patients requiring vasopressors. Drug resistant bacteria strains: patient was most likely not responding to broad spectrum antibiotics before binaxnow testing (presumably as the reason for testing legionella). Patient also didn't respond to broad spectrum antibiotics after the negative testing from the reference lab. Other factors are also considered for this conclusion: levofloxacin is a widely used antibiotics and it is unlikely the side effect of levofloxacin caused or contributed to the patient death. There is sufficient warning in the product package insert and labeling that the diagnosis of legionnaires' disease cannot be based on clinical or radiological evidence alone. The binaxnow has lower specificity than binax ela and bartels according the label (95% vs. 100%). Attempts have been made to obtain additional information from the hospital. On (b)(6) 2019, the customer replied to a request for additional information on the date of the death indicating that they do not have the date of death and information will not become available. The results of additional laboratory testing was not provided by the customer. On (b)(6) 2019, a site visit was conducted by abbott personnel. In summary: the hospital is not associating the alere binaxnow legionella urinary antigen card test result with the death of the patient. There were no serious concerns raised around the binaxnow legionella urinary antigen card test result being different from the reference lab. The lab was interested in learning if abbott has sensitivity data between the alere reader / binaxnow legionella urinary antigen card test versus binax now eia plate and/or bartells eia plate. They were questioning if the alere reader / binaxnow legionella urinary antigen card test is in fact more sensitive than the 2x eia plates used by the reference lab and hence, they got the alere reader / binaxnow legionella urinary antigen card test positive results and the test card was also visibly positive (4x repeats all on the same sample compared to the one test performed at and by the ref lab with the 2x eia plates). If it is that the case that alere reader / binaxnow legionella urinary antigen card test is more sensitive, then the lab may consider not sending positive samples to colindale (the reference lab). This would be a clinician dependant decision. The time frames from when the sample was taken to when it was tested in the lab, how it was stored and how it was transported to the reference lab were discussed. It is likely it was 2 to possibly 4 days from when the sample was taken, to when the sample was tested at the reference lab. The lab was unable to provide additional information on the patient and no additional circumstances of the patient death were provided.
Patient Sequence No: 1, Text Type: N, H10
[137670118]
On (b)(6) 2019, the death of a (b)(6) male patient at an intensive treatment unit in (b)(6) was reported (actual date of death not available). The patient was tested with the alere binaxnow legionella urinary antigen card test (pn 852-100) on (b)(6) 2019 with positive results generated. The test was repeated again shortly after and generated repeat positive results. Based on the binaxnow results, "broad spectrum antibiotics" were stopped and the patient was treated with levofloxacin for the suspected legionella pneumonia. The same urine sample was tested on the bartels legionella eia and binax legionella eia test on (b)(6) 2019 and was confirmed negative by both assays. The patient sample was tested a third time with the binaxnow legionella urinary antigen card test on (b)(6) 2019 and generated positive results. When the patient didn't clinically respond, treatment was changed to "broadened antibiotics" - the date of treatment change is unknown. Please note the alere binaxnow legionella urinary antigen card pn 852-100 is not available for sale in the us, however it is similar to the us available pn 852-000. The only difference between the two tests is pn 852-100 allows test results to be read visually or with the alere reader. Other factors: no or unknown blood culture results of legionella; no or unknown pcr results of legionella; unknown specific antibiotics usage ("broad spectrum antibiotics) prior to or levofloxacin usage and the patient response to the antibiotics; unknown specific antibiotics for "the broadened antibiotics again"; unknown comorbidities or other health conditions or other treatments such as intubation or vasopressor usage, unknown reasons of death, no reported valid lot number from the hospital. Although it is highly unlikely that a "false positive" test caused or contributed to the patient death in this case, information to rule out the possibility that the "false positive" caused or contributed to the death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221359-2019-00013 |
| MDR Report Key | 8384153 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-01 |
| Date of Report | 2019-03-01 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-02-12 |
| Device Manufacturer Date | 2018-06-15 |
| Date Added to Maude | 2019-03-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BENJAMIN CRYSTAL |
| Manufacturer Street | 10 SOUTHGATE ROAD |
| Manufacturer City | SCARBOROUGH ME 04074 |
| Manufacturer Country | US |
| Manufacturer Postal | 04074 |
| Manufacturer Phone | 2077305820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALERE BINAXNOW LEGIONELLA URINARY ANTIGEN TEST |
| Generic Name | IVD FOR LEGIONELLA |
| Product Code | MJH |
| Date Received | 2019-03-01 |
| Catalog Number | 852-100 |
| Lot Number | E07293 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SCARBOROUGH INC. |
| Manufacturer Address | 10 SOUTHGATE ROAD SCARBOROUGH ME 04074 US 04074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-03-01 |