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 2017-04-10 for ADVIA CENTAUR XP PROGESTERONE (PRGE) N/A 10315522 manufactured by Siemens Healthcare Diagnostics, Inc..
[72398275]
The cause for the discordant low advia centaur xp progesterone (prge) results compared to the alternate laboratory and progesterone test method is unknown. Siemens is investigating. The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. "
Patient Sequence No: 1, Text Type: N, H10
[72398276]
Falsely low advia centaur xp progesterone (prge) results were observed by the customer on a patient receiving progesterone therapy. The sample results were taken consecutively, however the third sample was taken after a medication dose increase to 16 mg per day. The physician was expecting a higher progesterone result. The patient was tested at an alternate laboratory, with an alternate progesterone test method, and the result was elevated. The patient was retested at another facility (hospital), on an alternate progesterone test method, and the result was low. No corrective result was reported by the customer. There was no report of adverse health consequences due to the increased dosing, and discordant low advia centaur xp progesterone assay results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00093 |
| MDR Report Key | 6477664 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-10 |
| Date of Report | 2017-04-10 |
| Date of Event | 2017-03-16 |
| Date Mfgr Received | 2017-03-16 |
| Device Manufacturer Date | 2016-03-25 |
| Date Added to Maude | 2017-04-10 |
| 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 | STEPHEN PERRY |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 105915097 |
| Manufacturer Country | US |
| Manufacturer Postal | 105915097 |
| Manufacturer Phone | 5086604163 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST 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 PROGESTERONE (PRGE) |
| Generic Name | PROGESTERONE IMMUNOASSAY |
| Product Code | JLS |
| Date Received | 2017-04-10 |
| Model Number | N/A |
| Catalog Number | 10315522 |
| Lot Number | 059275 |
| Device Expiration Date | 2017-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-04-10 |