MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-26 for IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG KIT 200T TOXOPLASMA QUANTITATIVE IGG ASSAY (TXP) L2KTXP2 manufactured by Siemens Healthcare Diagnostics Products, Limited.
| Report Number | 2432235-2019-00333 |
| MDR Report Key | 9125532 |
| Date Received | 2019-09-26 |
| Date of Report | 2019-10-28 |
| Date of Event | 2019-07-11 |
| Date Mfgr Received | 2019-10-15 |
| Date Added to Maude | 2019-09-26 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MIR KHAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10951 |
| Manufacturer Country | US |
| Manufacturer Postal | 10951 |
| Manufacturer Phone | 9145243074 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | GLYN RHONWY UK REGISTRATION #: 3002806944 |
| Manufacturer City | LLANBERIS, LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG KIT 200T |
| Generic Name | TOXOPLASMA QUANTITATIVE IGG ASSAY (TXP) |
| Product Code | LGD |
| Date Received | 2019-09-26 |
| Model Number | TOXOPLASMA QUANTITATIVE IGG ASSAY (TXP) |
| Catalog Number | L2KTXP2 |
| Lot Number | 446 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Address | GLYN RHONWY LLANBERIS, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-26 |