MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-23 for ADVIA CENTAUR CP PROGESTERONE (PRGE) N/A 02382928 manufactured by Siemens Healthcare Diagnostics, Inc..
[17974780]
A falsely elevated advia centaur cp result was obtained by the customer and considered discordant when compared to repeat dilution test results and another centaur system. The falsely elevated progesterone result was not reported by the customer. There was no report of adverse health consequences due to the discordant advia centaur cp progesterone result.
Patient Sequence No: 1, Text Type: D, B5
[18023178]
A siemens field service engineer (fse) was sent to the customer site for system inspection. The fse observed air in the reagent syringe line and replaced the syringe, however replacement of the reagent syringe is not likely the cause. The discordant sample was rerun after the service visit and the result was 52 ng/ml. No conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2012-00072 |
| MDR Report Key | 2466280 |
| Report Source | 05,06 |
| Date Received | 2012-02-23 |
| Date of Report | 2012-02-04 |
| Date of Event | 2012-02-04 |
| Date Mfgr Received | 2012-02-04 |
| Date Added to Maude | 2012-08-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY ST. |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR CP PROGESTERONE (PRGE) |
| Generic Name | PROGESTERONE |
| Product Code | JLS |
| Date Received | 2012-02-23 |
| Model Number | N/A |
| Catalog Number | 02382928 |
| Lot Number | 257 |
| Device Expiration Date | 2012-09-14 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-02-23 |