MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-19 for ADVIA CENTAUR XP PROGESTERONE (PRGE) N/A 02382928 manufactured by Siemens Healthcare Diagnostics, Inc..
[2763895]
A false low advia centaur xp progesterone result was obtained by the customer on a patient sample and the result was questioned by the physician. The customer performed repeat testing on the discordant sample and the result was higher and aligned with the patient's clinical picture. There was no report of adverse health consequences due to the discordant advia centaur xp progesterone result.
Patient Sequence No: 1, Text Type: D, B5
[9919883]
The cause for the initially discordant low result when compared to the patient's clinical picture and the repeat test result is unknown. The customer's quality control results were within acceptable limits and there were no other known discordant progesterone patient results reported. No conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2012-00245 |
| MDR Report Key | 2621689 |
| Report Source | 05,06 |
| Date Received | 2012-06-19 |
| Date of Report | 2012-05-24 |
| Date of Event | 2012-05-21 |
| Date Mfgr Received | 2012-05-24 |
| Date Added to Maude | 2012-10-12 |
| 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 XP PROGESTERONE (PRGE) |
| Generic Name | PROGESTERONE |
| Product Code | JLS |
| Date Received | 2012-06-19 |
| Model Number | N/A |
| Catalog Number | 02382928 |
| Lot Number | 258 |
| 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 | 2012-06-19 |