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 2019-05-22 for ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) ASSAY N/A 10699154 manufactured by Siemens Healthcare Diagnostics, Inc..
[146377946]
The high results were reported on april 16th and april 25th. The quality control and calibrations were checked and were acceptable. All the results were from the same reagent pack. All the repeated samples were using the same tube. A field service engineer (fse) was dispatched to the customer site. Awaiting the details of the fse report to be provided. Siemens healthcare diagnostics is awaiting further information. The interpretation of results of the instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings". The limitations section of the instructions for use states: "interpretation of intact pth values should always take into account serum calcium results and the interrelationship between these 2 elements in various disorders involving pth and calcium. It is recommended that the intact pth results should always be interpreted with caution and with consideration of the overall clinical manifestations even when used in conjunction with calcium values.. ". Mdr 1219913-2019-00094 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[146377947]
Discordant high advia centaur xp intact parathyroid hormone (pth) results were obtained for a "big amount" of patient samples. The results were higher than expected. The samples were repeated, and the results were lower. It is unknown if patient treatment was prescribed or altered. There was no report of adverse health consequences as a result of the discordant pth result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2019-00081 |
| MDR Report Key | 8632776 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-22 |
| Date of Report | 2019-06-18 |
| Date of Event | 2019-04-16 |
| Date Mfgr Received | 2019-05-30 |
| Device Manufacturer Date | 2018-10-05 |
| Date Added to Maude | 2019-05-22 |
| 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 | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) ASSAY |
| Generic Name | PTH IMMUNOASSAY |
| Product Code | CEW |
| Date Received | 2019-05-22 |
| Model Number | N/A |
| Catalog Number | 10699154 |
| Lot Number | 24274021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-22 |