MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-03-07 for ADVIA CENTAUR XP PROGESTERONE (PRGE) N/A 02382928 manufactured by Siemens Healthcare Diagnostics, Inc..
[39784052]
Siemens is filing the mdr conservatively as a result of the data included in the article. Siemens is unaware of the lots used to generate the published data. It is unknown the potential cross reactivity of supraphysiological concentrations of (b)(6) with the progesterone advia centaur assay. Siemens is investigating.
Patient Sequence No: 1, Text Type: N, H10
[39784053]
Siemens was notified by the customer to an article publication in the journal of assisted reproduction and genetics suggesting interference from (b)(6) in the advia centaur progesterone assay causing falsely elevated progesterone results. There are no reports of adverse health consequences for falsely elevated advia centaur progesterone results and interference of (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[64757022]
Siemens filed the initial mdr 1219913-2016-00051 on 03/07/2016. The customer had notified siemens with regards to an article publication in the journal of assisted reproduction and genetics suggesting interference from dheas in the advia centaur progesterone assay causing falsely elevated progesterone results. On 12/29/2016 - additional information: siemens investigated cross-reactivity of dhea-s in the advia centaur xp progesterone assay, dimension vista loci progesterone assay, immulite/immulite 1000 progesterone assay and immulite 2000 progesterone assay and confirmed that dhea-s may cause elevated progesterone results in these assays. Dhea-s may be used as part of an ivf treatment plan for patients who are also being considered for fresh embryo transfer. A falsely elevated progesterone result around the clinical decision threshold of approximately 1. 0 ng/ml may lead to misinterpretation of progesterone levels and consideration of fresh embryo transfer cancellation and subsequent cryopreservation of the embryo(s). Siemens distributed urgent medical device correction cc 17-06. A. Us to customers in the united states and urgent field safety notice cc 17-06. A. Ous to customers outside the united states on january 4, 2017. These communications notify customers of the crossreactivity of dhea-s in the assays and advise customers to use an alternate method such as liquid chromatography- mass spectrometry (lc-ms) when measuring progesterone in patients using dhea-s supplements. No further investigation is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00051 |
| MDR Report Key | 5483561 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-07 |
| Date of Report | 2017-01-10 |
| Date of Event | 2016-02-10 |
| Date Mfgr Received | 2016-12-29 |
| Date Added to Maude | 2016-03-07 |
| 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 | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| 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 |
| Removal Correction Number | 1219913-01/04/2017-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP PROGESTERONE (PRGE) |
| Generic Name | PROGESTERONE IMMUNOASSAY |
| Product Code | JLS |
| Date Received | 2016-03-07 |
| Model Number | N/A |
| Catalog Number | 02382928 |
| 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, INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-07 |