MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-10-23 for DIRECTIGEN 123 GROUP A STREP KIT NOT APPLICABLE 252540 manufactured by Becton Dickinson.
[16787768]
Customer states they are seeing decreased sensitivity when using the directigen 123 group a strep kit with the culture swab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2001-00006 |
| MDR Report Key | 358163 |
| Report Source | 06 |
| Date Received | 2001-10-23 |
| Date of Report | 2001-10-12 |
| Date of Event | 2001-08-24 |
| Date Mfgr Received | 2001-08-27 |
| Date Added to Maude | 2001-10-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164464 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIRECTIGEN 123 GROUP A STREP KIT |
| Generic Name | GROUP A STREPTOCOCCUS TEST SYSTEM |
| Product Code | GTY |
| Date Received | 2001-10-23 |
| Returned To Mfg | 2001-09-05 |
| Model Number | NOT APPLICABLE |
| Catalog Number | 252540 |
| Lot Number | 1187951 |
| ID Number | NOT APPLICABLE |
| Device Expiration Date | 2001-12-04 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 347370 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US |
| Baseline Brand Name | DIRECTIGEN 123 GROUP A STREP KIT |
| Baseline Catalog No | 252540 |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 6 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K951542 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-10-23 |