MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-25 for IMMULITE 2000 ESTRADIOL (E2) 10702834 (LKE22) manufactured by Siemens Healthcare Diagnostics Products, Limited.
| Report Number | 2432235-2020-00197 |
| MDR Report Key | 9751689 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-25 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 5243074 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | GLYN RHONWY UK REGISTRATION #: 3002806944 |
| Manufacturer City | LLANBERIS, GWYNEDD LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-02/10/2020-003-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 ESTRADIOL (E2) |
| Generic Name | IMMULITE 2000 ESTRADIOL (E2) ASSAY |
| Product Code | CHP |
| Date Received | 2020-02-25 |
| Model Number | IMMULITE 2000 ESTRADIOL |
| Catalog Number | 10702834 (LKE22) |
| Lot Number | 504 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Address | GLYN RHONWY LLANBERIS, GWYNEDD LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |