MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-11-21 for IMMULITE 2000 XPI 030001-03 manufactured by Siemens Healthcare Diagnostics Inc..
[20128663]
Discordant, falsely low alphafeto protien (afp), human chorionic gonadatropin (hcg) and unconjugated estriol (ue3) results were obtained on one patient sample on an immulite 2000 xpi instrument. The falsely low afp, hcg and ue3 results were not reported to the physician(s). The same sample was repeated on same instrument and resulted higher than the initial low results. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low afp, hcg and ue3 results.
Patient Sequence No: 1, Text Type: D, B5
[20261306]
A siemens field service engineer (fse) was dispatched to the customer site. The fse evaluated the instrument, including sample pipetting, fluids, level sensing and the grounding of the sample carousel, and did not find an instrument malfunction. A siemens headquarters support center (hsc) specialist reviewed the instrument data. The quality controls for all levels and adjustments for all three assays were within acceptable ranges. The cause of discordant, falsely low afp, hcg and ue3 results is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2014-00081 |
| MDR Report Key | 4268992 |
| Report Source | 01,05,06 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-10-29 |
| Date of Event | 2014-10-28 |
| Date Mfgr Received | 2014-10-29 |
| Date Added to Maude | 2014-12-02 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 XPI |
| Generic Name | IMMULITE 2000 XPI |
| Product Code | JJQ |
| Date Received | 2014-11-21 |
| Model Number | IMMULITE 2000 XPI |
| Catalog Number | 030001-03 |
| 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 | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-21 |