MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for IMMULITE 2000 FSH L2KFS2 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[67268684]
The cause of the discordant, falsely elevated fsh results on one patient sample is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[67268685]
The customer obtained discordant, falsely elevated follicular stimulating hormone (fsh) results on one patient sample upon initial and repeat testing on an immulite 2000 xpi instrument, when using reagent lot 326. The discordant results were reported to the physician(s), who questioned them. The sample was repeated on two alternate platforms, resulting lower each time and matching the clinical picture of the patient. The corrected result obtained on the 2nd alternate platform was reported to the physician(s). There are no known reports of patient intervention or adverse health consequence due to the discordant, falsely elevated fsh result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00085 |
| MDR Report Key | 6311756 |
| Date Received | 2017-02-08 |
| Date of Report | 2017-02-08 |
| Date of Event | 2017-01-13 |
| Date Mfgr Received | 2017-01-16 |
| Date Added to Maude | 2017-02-08 |
| 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 | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | 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 FSH |
| Generic Name | IMMULITE 2000 FSH |
| Product Code | CGJ |
| Date Received | 2017-02-08 |
| Model Number | IMMULITE 2000 FSH |
| Catalog Number | L2KFS2 |
| Lot Number | 326 |
| 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 | REGISTRATION #: 3002806944 GLYN RHONWY LLANBERIS, GWYNEDD, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-08 |