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..
[114817627]
Testing was performed at alere (b)(4) on retained device lots 905626 and 905882 associated with kit lots e05925 and e05858 with presumed negative urine samples and a positive control. All test results were valid and performed as expected. Additionally, the manufacturing batch records for lots 905626 and 905882 were reviewed. These lots met the required release specifications. A review of the complaints reported false positives related to lot numbers 905626 and 905882 showed no similar cases. 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
[114817628]
The customer reported that 4 weak (false) positive results were obtained with the alere binaxnow streptococcus pneumoniae antigen card test. The (frozen) samples were tested again (b)(6) 2017 with a second lot of material and 3 of the 4 samples generated weak positive results. The result of the 4th sample is unknown and therefore it is unknown if a false negative result occurred. The sample type and patient outcome(s) are unknown. The conflicting results suggest a malfunction may have occurred. In a worst case scenario if cerebral spinal fluid (csf) was used, 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, 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 | 1221359-2018-00475 |
| MDR Report Key | 7699640 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-18 |
| Date of Report | 2018-07-18 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2017-03-29 |
| 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 | E05845 |
| Device Expiration Date | 2019-01-01 |
| 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 |