MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-11-08 for ATELLICA IM PROGESTERONE (PRGE) N/A 10995659 manufactured by Siemens Healthcare Diagnostics, Inc..
[165762902]
The cause for the discordant progesterone results is unknown. Siemens healthcare diagnostics is investigating. The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings. " mdr 1219913-2019-00231 (sid (b)(6), atellica 2 result) was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[165762903]
A discordant high atellica im progesterone (prge) result was obtained on a patient sample. The result was reported to the physician and questioned. The patient was retested on another atellica im analyzer and the result was high. The patient sample was tested on an alternate method and the result was lower. A corrected report was issued. The patient is on in vitro fertilization (ivf) protocol. The ivf protocol was postponed. There was no report of adverse health consequences due to the discordant progesterone results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2019-00230 |
| MDR Report Key | 9296278 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-11-08 |
| Date of Report | 2019-11-08 |
| Date of Event | 2019-10-11 |
| Date Mfgr Received | 2019-10-28 |
| Device Manufacturer Date | 2018-11-09 |
| Date Added to Maude | 2019-11-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATELLICA IM PROGESTERONE (PRGE) |
| Generic Name | PROGESTERONE IMMUNOASSAY |
| Product Code | JLS |
| Date Received | 2019-11-08 |
| Model Number | N/A |
| Catalog Number | 10995659 |
| Lot Number | 10973288 |
| Device Expiration Date | 2019-11-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-08 |