MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-28 for IMMULITE 2000 UNCONJUGATED ESTRIOL IMMULITE 2000 UE3 L2KUE32 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[71237389]
The cause of the low ue3 results with kit lot 309 is unkown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[71237390]
The customer observed a low median distribution of patient results for unconjugated estriol with reagent lot 309 on an immulite 2000 instrument. The initial results have been reported to physician(s) who questioned the results. Repeat testing was not performed on the samples to verify the results. It is unknown if any medical intervention was performed on the patients due to the low unconjugated estriol results. It is unknown if there was any delay in administering treatment or medical intervention to patients due to the low unconjugated estriol results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00223 |
| MDR Report Key | 6438534 |
| Date Received | 2017-03-28 |
| Date of Report | 2017-03-28 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-03-09 |
| Date Added to Maude | 2017-03-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DEVYANI CHAUDHURI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242637 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | UK REGISTRATION #: 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, GWYNEDD LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IMMULITE 2000 UNCONJUGATED ESTRIOL |
| Generic Name | IMMULITE 2000 UNCONJUGATED ESTRIOL |
| Product Code | CGI |
| Date Received | 2017-03-28 |
| Model Number | IMMULITE 2000 UE3 |
| Catalog Number | L2KUE32 |
| Lot Number | 309 |
| Device Expiration Date | 2017-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-03-28 |