MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-12 for IMMULITE 2000 FSH manufactured by Siemens Healthcare Diagnostics Products, Limited.
[72499176]
The customer contacted a siemens customer care center and stated that their quality controls were within acceptable range. The cause of the discordant, falsely low fsh results on one patient sample is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[72499177]
The customer obtained discordant falsely low follicle stimulating hormone (fsh) results on one patient sample upon initial and repeat testing on an immulite 2000 xpi instrument, while using reagent lot 326. The sample was repeated on two alternate platforms, resulting higher each time and matching the clinical picture of the patient. The discordant results were reported to the physician(s), who questioned them. The result obtained on the 2nd alternate platform was reported as a correct result to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low fsh results.
Patient Sequence No: 1, Text Type: D, B5
[75944406]
The initial mdr 2432235-2017-00226 was filed on april 12, 2017. Additional information (04/27/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer. It was unknown what medications were taken by the patient. The hsc specialist stated that there was no device issue. The hsc specialist also stated that as the discordant results were reproducible on the immulite 2000 xpi instrument only affecting one patient sample, it rules out any mechanical issue. Siemens is unable to perform in-house testing as the patient sample is not available for further evaluation. The cause of the discordant, falsely low fsh results on one patient sample is unknown. The device is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00226 |
| MDR Report Key | 6484846 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-12 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-03-14 |
| Date Mfgr Received | 2017-04-27 |
| Date Added to Maude | 2017-04-12 |
| 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 | 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 | 3 |
| Brand Name | IMMULITE 2000 FSH |
| Generic Name | IMMULITE 2000 FSH |
| Product Code | CGJ |
| Date Received | 2017-04-12 |
| Model Number | IMMULITE 2000 FSH |
| Lot Number | 326 |
| 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 | 2017-04-12 |