MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-05 for B-D DIRECTIGEN EZ KIT FOR RSV RAPID ANTIGEN * B694410 manufactured by Becton Dickinson.
[1139924]
Respiratory syncytial virus (rsv) rapid antigen assays were ordered on patients on two consecutive days. After thirteen results were reported positive using the becton dickinson directigen ez kits, the director was notified as well as the medical director of hospital epidemiology & infection control. Rsv antigen assays were followed up with pcr and culture for confirmation. Bd technical services were notified and a conference call followed three days after the reported positive results. We had a total of seventeen positives and all seventeen were false positives. Bd scientific group came to our lab ten days later following the conference call to run the samples to see if they could determine the problem. Lot numbers included 8296111, 8330466 and 829126. Awaiting bd's evaluation of the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1381551 |
| MDR Report Key | 1381551 |
| Date Received | 2009-05-05 |
| Date of Report | 2009-05-04 |
| Date of Event | 2009-04-11 |
| Report Date | 2009-05-04 |
| Date Reported to FDA | 2009-05-05 |
| Date Added to Maude | 2009-05-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | B-D DIRECTIGEN EZ KIT FOR RSV RAPID ANTIGEN |
| Generic Name | LAB REAGENT KIT |
| Product Code | GQG |
| Date Received | 2009-05-05 |
| Model Number | * |
| Catalog Number | B694410 |
| Lot Number | 8296111, 8330466, 8296126 |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE; MC2266 FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-05 |