MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-05 for SLIDEX ROTA KIT 2 * manufactured by Biomerieux Vitek, Inc..
[87417]
A kit called slidex rota kit 2, used for detecting the antigen of the group of viruses called rotavirus, and marketed by biomerieux vitek, with offices at 595 angium drive, hazelwood, mo 63042, states in its package insert "do not interchange reagents between different lot numbers. However, the kits contain three vials each with a different lot no, and the box contains a yet different number. How is the customer to know whether the vials were assembled correctly by the mfr if there are no clues as to which numbers go together and which ones do not match? At the very least, the box or the package insert should give a key to the lot numbers of the vials that belong in that box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012955 |
| MDR Report Key | 147761 |
| Date Received | 1998-02-05 |
| Date Added to Maude | 1998-02-10 |
| 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 |
| 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 | SLIDEX ROTA KIT 2 |
| Generic Name | ROTAVIRUS ANTIGEN DETECTOR KIT |
| Product Code | LIQ |
| Date Received | 1998-02-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 143985 |
| Manufacturer | BIOMERIEUX VITEK, INC. |
| Manufacturer Address | 595 ANGIUM DR. HAZELWOOD MO 63042 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-02-05 |