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 2016-04-01 for IMMULITE 2000 XPI 030001-3 manufactured by Siemens Healthcare Diagnostics Inc..
[41683661]
Siemens headquarters support center (hsc) reviewed the instrument files provided by the customer. There were no errors and nothing observed in the instrument files that indicated a malfunction in the instrument while the sample was being processed. A siemens field service engineer (fse) visited the customer site the day after the falsely low discordant was observed ((b)(6) 2016) and evaluated the instrument based on suggestions made by hsc. The issue with the system as per the fse was a earthing problem. There have been no other discordant results reported by the customer since the fse evaluated the instrument. The cause of the falsely low results was due to an earthing problem of the instrument. The system is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[41683662]
The customer obtained a falsely low result for the homocysteine assay on the immulite 2000 xpi, after switching to a new reagent lot 329. The sample was repeated again in duplicate and the results were acceptable to the customer. It is unknown if the initial or repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the falsely low result obtained on the immulite 2000 xpi instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2016-00019 |
| MDR Report Key | 5541812 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-01 |
| Date of Report | 2016-03-08 |
| Date of Event | 2016-03-08 |
| Date Mfgr Received | 2016-03-08 |
| Date Added to Maude | 2016-04-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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, 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 | LPS |
| Date Received | 2016-04-01 |
| Model Number | IMMULITE 2000 XPI |
| Catalog Number | 030001-3 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY ROAD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-01 |