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 2017-01-10 for ADVIA CENTAUR XP PROGESTERONE (PRGE) N/A 10310305 manufactured by Siemens Healthcare Diagnostics, Inc..
[64429796]
An mdr was not initially filed for this complaint as no injury was described. A progesterone measurement of 0. 63 ng/ml when 0 ng/ml in most instances is not considered clinically significant as both measurements are either within or below the expected reference interval depending on timing of the test. 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
[64429797]
Customer contacted siemens requesting information regarding cross-reactivity of dhea-s with the advia centaur xp progesterone assay. The customer noted that there have been elevated progesterone results from patients who were taking dhea-s the customer reported that some doctors have taken their patients off of dhea-s. There are no reports of adverse health consequences due to the elevated advia centaur xp progesterone results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2016-00273 |
| MDR Report Key | 6238212 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-10 |
| Date of Report | 2017-01-10 |
| Date of Event | 2015-12-21 |
| Date Mfgr Received | 2015-12-21 |
| Date Added to Maude | 2017-01-10 |
| 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 | LOUISE MCLAUGHLIN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604381 |
| 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 |
| Remedial Action | RC |
| 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 | 2017-01-10 |
| Model Number | N/A |
| Catalog Number | 10310305 |
| Lot Number | 273 |
| Device Expiration Date | 2016-08-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2017-01-10 |