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..
[114818012]
Testing was performed at alere (b)(4) on retained device lot e04320 associated with kit lot e04787 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 e04320 were reviewed. This lot met the required release specifications. A review of the complaints reported false negative and false positives related to lot number e04787 showed no similar cases for false positive results and one case for false negative (urine). 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
[114818013]
The customer reported that a positive result was obtained on a cerebral spinal fluid with the alere binaxnow streptococcus pneumoniae antigen card test. The same sample was tested again, after it had been frozen and returned a negative result. Based on the information available, it appears a malfunction may have occurred with the conflicting binaxnow streptococcus pneumoniae antigen card tests. In a worst case scenario with cerebral spinal fluid (csf), a false negative result could have occurred. 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. In this case, at 48 hours, the culture was sterile. 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 | 1221359-2018-00472 |
| MDR Report Key | 7699638 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-18 |
| Date of Report | 2018-07-18 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2016-03-31 |
| 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 | E04787 |
| Device Expiration Date | 2017-12-01 |
| 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 |