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 710-012 manufactured by Alere Scarborough Inc..
[114817746]
Testing was performed at alere (b)(4) on retained device lot 905495 associated with kit lot e05496 with presumed negative urine samples and low positive controls. All test results were valid and performed as expected. Additionally, the manufacturing batch records for lot 905495 were reviewed. This lot met the required release specifications. A review of the complaints reported as false negative related to lot number 905495 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
[114817747]
The customer reported a few cases in which pneumococcus was present in the blood culture but the alere binaxnow streptococcus pneumoniae antigen card test was negative. The date or dates occurence and the exact number of patients or tests involved is unknown. There is insufficient information to determine if a malfunction occurred. The sample type and patient(s) outcome are unknown. In a worst case scenario the false negative results could have occurred in cerebral spinal fluid (csf). A false negative result may cause a delay in the patient receiving appropriate therapy. As meningitis is a serious, lifethreatening 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 | 1221359-2018-00473 |
| MDR Report Key | 7699644 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-18 |
| Date of Report | 2018-07-18 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2016-12-12 |
| 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 | 710-012 |
| Lot Number | E05496 |
| Device Expiration Date | 2018-10-01 |
| 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 |