MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-26 for BD (BECTON-DICKINSON) 21801 manufactured by Becton Dickinson Microbiology Systems.
[62110]
Unable to obtain valid qc. Results for strep pneumoniae susceptibility testing with trimethoprim/sulfa. (inquiry on the internet showed that other labs had same problem).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011566 |
| MDR Report Key | 101026 |
| Date Received | 1997-06-26 |
| Date of Report | 1997-06-23 |
| Date of Event | 1997-03-01 |
| Date Added to Maude | 1997-06-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD (BECTON-DICKINSON) |
| Generic Name | BLOOD MUELLER HINTON |
| Product Code | JTZ |
| Date Received | 1997-06-26 |
| Model Number | NA |
| Catalog Number | 21801 |
| Lot Number | C3RWWM,B3RWCA |
| ID Number | * |
| Device Expiration Date | 1997-04-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 99529 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | P.O. BOX 243 COCKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-26 |