MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM manufactured by Bio-rad Laboratories, Inc..
[178756683]
Since initiation of using biorad bioplex 2200 syphilis total and rpr reagent pack the positivity rate has dramatically increased, while confirmation testing has revealed large number of (b)(6). Fda safety report id # (b)(4). Fda received date 02/06/2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092883 |
| MDR Report Key | 9693598 |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-06 |
| Date Added to Maude | 2020-02-11 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM |
| Generic Name | BIORAD VIOPLEX 2200 SYPHILIS TOTAL AND RPR |
| Product Code | LIP |
| Date Received | 2020-02-10 |
| Lot Number | 301023 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES, INC. |
| Brand Name | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM |
| Generic Name | BIORAD VIOPLEX 2200 SYPHILIS TOTAL AND RPR |
| Product Code | LIP |
| Date Received | 2020-02-10 |
| Lot Number | 301063 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |