MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-24 for IMMULITE/IMMULITE 1000 PROGESTERONE N/A LKPW1 manufactured by Siemens Healthcare Diagnostics.
[2659664]
A discordant progesterone result was obtained on an immulite 1000 for one patient sample. It is unknown whether the discordant result was reported to a physician. Siemens attempted to contact the customer a number of times and left messages to get further information, but there was no return response from the customer. There were no changes to patient treatment due to the discordant progesterone result.
Patient Sequence No: 1, Text Type: D, B5
[9885184]
After a review by a siemens technical applications specialist, the cause for the discordant progesterone result is unknown. Due to the length of time between the test and the notification to siemens of the data, the sample quality (e. G type, collection information, transport information, potential for bubbles in the sample, etc) was not able to be verified. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00144 |
| MDR Report Key | 2587664 |
| Report Source | 05,06 |
| Date Received | 2012-05-24 |
| Date of Report | 2012-05-01 |
| Date of Event | 2012-02-14 |
| Date Mfgr Received | 2012-05-01 |
| Date Added to Maude | 2012-09-27 |
| 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 | MICHAEL METZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | GLYN RHONWY LLANBERIS, CAERNARFON |
| Manufacturer City | GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE/IMMULITE 1000 PROGESTERONE |
| Generic Name | IMMUOASSAY ANALYZER |
| Product Code | JLS |
| Date Received | 2012-05-24 |
| Model Number | N/A |
| Catalog Number | LKPW1 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | GLYN RHONWY LLANBERIS, CAERNARFON GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-24 |