MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-07-02 for ADVIA CENTAUR XP PROGESTERONE (PRGE) ASSAY N/A 01586287 manufactured by Siemens Healthcare Diagnostics, Inc..
[4582620]
The customer observed an elevated advia centaur xp progesterone (prge) patient result that did not reproduce upon repeat testing. There are no reports that treatment was altered or prescribed based on the elevated result. There are no reports or adverse health consequences based on the elevated advia centaur xp prge result.
Patient Sequence No: 1, Text Type: D, B5
[12142316]
The cause for the non-reproducible elevated advia centaur xp prge result is unknown. Quality control results were acceptable. No other reports of non-reproducible prge results have been reported by this customer on this system since this report. A field service engineer went on site and had no relevant findings. The sample is no longer available for testing but repeat testing on a second advia centaur showed comparable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2014-00162 |
| MDR Report Key | 3909451 |
| Report Source | 01,05,06 |
| Date Received | 2014-07-02 |
| Date of Report | 2014-06-10 |
| Date of Event | 2004-06-02 |
| Date Mfgr Received | 2014-06-10 |
| Date Added to Maude | 2014-07-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP PROGESTERONE (PRGE) ASSAY |
| Generic Name | PROGESTERONE IMMUNOASSAY |
| Product Code | JLS |
| Date Received | 2014-07-02 |
| Model Number | N/A |
| Catalog Number | 01586287 |
| Lot Number | 059264 |
| ID Number | N/A |
| Device Expiration Date | 2014-10-18 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-07-02 |