MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-15 for IMMULITE 2000 030002 manufactured by Siemens Healthcare Diagnostics.
[5213073]
A discordant falsely low value was obtained on one patient sample for the estradiol assay on an immulite 2000 instrument. The customer ran the patient sample neat and at a 1:3 dilution. The sample was then repeated neat twice on the same instrument. The result obtained at the 1:3 dilution was falsely low. The repeated result on the neat sample was reported to the physician(s). There were no known reports of patient intervention or adverse health consequences due to the falsely low estradiol result.
Patient Sequence No: 1, Text Type: D, B5
[12665300]
A siemens field service engineer (fse) was dispatched to the customer site. The fse reviewed the instrument files and did not find any errors during the time the sample was run. The fse found a gel like substance at the tip of the sample probe. The sample probe was replaced and the patient sample was run ten times, along with quality control samples on the immulite 2000 instrument to verify precision. The values obtained were within specifications. The cause of the falsely low estradiol value on the one patient sample 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 | 2247117-2014-00089 |
| MDR Report Key | 4330521 |
| Report Source | 05,06 |
| Date Received | 2014-12-15 |
| Date of Report | 2014-12-01 |
| Date of Event | 2014-11-26 |
| Date Mfgr Received | 2014-12-01 |
| Date Added to Maude | 2014-12-29 |
| 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 | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| 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 |
| Generic Name | IMMULITE 2000 |
| Product Code | JJQ |
| Date Received | 2014-12-15 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 030002 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 62 FLANDERS BARTLEY ROAD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-15 |