MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-27 for BECTON DICKINSON STREP A ANTIGEN DETECTION BD CHECK GROUP A STREP manufactured by Becton Dickinson.
[87843493]
Performing a proficiency testing mle m1 specimen rs-1 for streptococcus a. We had a negative result upon completion of the test. When we received our proficiency testing back from mle, they report that the result should have been positive. Was someone operating the medical device when the problem occurred: yes. If yes, who was using it: a health professional.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072515 |
| MDR Report Key | 6900165 |
| Date Received | 2017-09-27 |
| Date of Report | 2017-05-15 |
| Date of Event | 2017-02-09 |
| Date Added to Maude | 2017-09-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BECTON DICKINSON STREP A ANTIGEN DETECTION |
| Generic Name | BECTON DICKINSON STREP A ANTIGEN DETECTION |
| Product Code | GTY |
| Date Received | 2017-09-27 |
| Model Number | BD CHECK GROUP A STREP |
| Lot Number | #STA5110004 |
| Device Expiration Date | 2017-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Brand Name | BECKTON DICKINSON STREP A ANTIGEN DETECTION |
| Generic Name | BECKTON DICKINSON STREP A ANTIGEN DETECTION |
| Product Code | GTY |
| Date Received | 2017-09-27 |
| Model Number | BD CHECK GROUP A STREP |
| Lot Number | #STA5110004 |
| Device Expiration Date | 2017-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKTON DICKINSON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-27 |