MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-06-24 for IMMULITE 1000, PROGESTERONE LKPG manufactured by Siemens Healthcare Diagnostics.
[882829]
Elevated immulite 1000 progesterone results were reported to the physician on two pts samples. The physician questioned the results because the progesterone values were elevated relative to the pt's estradiol levels. Both pt samples were retested with another progesterone assay and the results were lower. Pt treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant progesterone results.
Patient Sequence No: 1, Text Type: D, B5
[8077950]
A siemens field service engineer (fse) was sent to the customer site. Analysis of the instrument and instrument data indicate that the cause for the discordant progesterone result is unk. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017183-2008-00022 |
| MDR Report Key | 1066026 |
| Report Source | 05,06 |
| Date Received | 2008-06-24 |
| Date of Report | 2008-03-12 |
| Date of Event | 2008-03-12 |
| Date Mfgr Received | 2008-03-12 |
| Date Added to Maude | 2009-05-06 |
| 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 | PUSHPINDER MARSHALL |
| Manufacturer Street | 5210 PACIFIC CONCOURSE DRIVE |
| Manufacturer City | LOS ANGELES CA 900456900 |
| Manufacturer Country | US |
| Manufacturer Postal | 900456900 |
| Manufacturer Phone | 3106458200 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | 5700 WEST 96TH ST. |
| Manufacturer City | LOS ANGELES CA 90045559 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90045 5597 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 1000, PROGESTERONE |
| Generic Name | IMMUNOASSAY SYSTEM |
| Product Code | JLX |
| Date Received | 2008-06-24 |
| Model Number | NA |
| Catalog Number | LKPG |
| Lot Number | 321 |
| Device Expiration Date | 2008-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | LOS ANGELES CA 90045 US 90045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-24 |