MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-28 for ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD 710-100 manufactured by Alere Scarborough, Inc..
[93576812]
Device kit lots used include: e05711 - manufactured 02/01/2017, expires 12/31/2018. E05738 - manufactured 02/09/2017, expires 10/31/2018. There are no similar cases of false positive results with csf for kit lots e05711 and e05738 that alere (b)(4) is aware of. The quality control release testing was reviewed for both lots of devices and there were no notes regarding false positive results. All qc tests were valid and performed within specifications. Testing with cerebral spinal fluid positive and cerebral spinal fluid negative samples demonstrated expected results when read visually and with the device compatible alere reader for both results. Review of complaint cases related to these lots revealed no similar cases related to false positive results with cerebral spinal fluid samples when devices were read visually (without the alere reader). The current complaint rate for the distributed device lots e05711 and e05738 are (b)(4). The photograph of the customer's used device (closed only, kit e05711) was reviewed. It appeared to be a valid, positive result with clearly visible control and sample lines. No background staining was observed. Alere (b)(4) intends to perform testing with the customer's returned sample x3 with both retain kit lots (read visually) when received. A follow up report will be provided. Alere (b)(4) would like to note that the device is not a standalone test; as described in the intended use it is to be used in conjunction with culture and other methods to aid in the diagnosis of both pneumococcal pneumonia and pneumococcal meningitis. Therefore, the risk of a false positive result is mitigated if followed. At this time, there is currently no evidence that the product is not performing according to the stated sensitivity and specificity claims but this incident will continue to be investigated.
Patient Sequence No: 1, Text Type: N, H10
[93576813]
Customer reported three false positive results for one patient with the alere binaxnow strep pneumoniae test using the same cerebral spinal fluid sample. The customer did not use the alere reader to interpret the tests - they were interpreted visually. The patient was given an unknown treatment based on the alere test result and was changed 24-hours later after confirmatory testing proved negative for s. Pneumo, but positive for listeria monocytogenes. No other adverse outcomes were reported - the patient remained in stable condition since final diagnosis of listeria meningitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221359-2017-00009 |
| MDR Report Key | 7065525 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-28 |
| Date of Report | 2017-10-26 |
| Date of Event | 2017-10-26 |
| Date Mfgr Received | 2017-10-26 |
| Device Manufacturer Date | 2017-02-01 |
| Date Added to Maude | 2017-11-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. EMILY DEANE |
| Manufacturer Street | 10 SOUTHGATE ROAD |
| Manufacturer City | SCARBOROUGH ME 04074 |
| Manufacturer Country | US |
| Manufacturer Postal | 04074 |
| Manufacturer Phone | 2077305809 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD |
| Generic Name | STREP PNEUMO ICT, BINAXNOW STREP PNEUMO TEST |
| Product Code | GTZ |
| Date Received | 2017-11-28 |
| Catalog Number | 710-100 |
| Lot Number | E05711 |
| Device Expiration Date | 2018-12-31 |
| 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 ROAD SCARBOROUGH ME 04074 US 04074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-28 |