MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-18 for ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD 710-100 manufactured by Alere Scarborough Inc..
[114818946]
Testing was performed at alere (b)(4) on retained device lot 905077 associated with kit lot e05116 with cerebral spinal fluid negative and positive quality controls. All test results were valid and performed as expected. Additionally, the manufacturing batch records for lot 905077 were reviewed. This lot met the required release specifications. A review of the complaints reported as false negative related to lot number 905077 showed no similar complaints. The evidence available does not indicate that the product is performing outside label claims. Alere (b)(4) was unable to determine the exact root cause of the reported issue. The available evidence suggests that this device lot is performing within labeled claims.
Patient Sequence No: 1, Text Type: N, H10
[114818947]
The customer reported that two cerebral spinal fluid (csf) samples collected from the same patient on two different days and tested with the alere binaxnow streptococcus pneumoniae antigen card test were negative. The csf sample was positive gram coloration and positive culture after 8 hours. The sample was sent to the national reference lab for confirmation testing and it was positive for s. Pneumoniae serotype 3. A false negative result may cause a delay in the patient receiving appropriate therapy. As meningitis is a serious, life threatening condition delays in treatment may have severe consequences; therefore, this is a reportable event. This mdr is a retrospective filing in response to an observation from an fda inspection conducted february 26th to march 2nd , 2018 at alere (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221359-2018-00474 |
| MDR Report Key | 7699625 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-18 |
| Date of Report | 2018-07-18 |
| Date of Event | 2016-11-28 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2016-08-16 |
| Date Added to Maude | 2018-07-18 |
| 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 STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD |
| Generic Name | ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP |
| Product Code | GTZ |
| Date Received | 2018-07-18 |
| Catalog Number | 710-100 |
| Lot Number | E05116 |
| Device Expiration Date | 2018-06-01 |
| 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 | 2018-07-18 |