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 2016-03-03 for IMMULITE 2000 XPI 030001-3 manufactured by Siemens Healthcare Diagnostics Inc..
[39649511]
A siemens field service engineer (fse) was dispatched to the customer site. The fse evaluated the immulite 2000 xpi and the reagent pack on the system. The fse ran a comparison study using a new reagent lot that was sent to the customer, and the old reagent lot that produced the falsely low result. The results obtained on the samples when using the new reagent lot were satisfactory to the customer. The customer is going to use the new reagent lot going forward. The cause of the falsely low result on the one patient sample is unknown. The system is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[39649512]
The customer has obtained a falsely low result for the homocysteine assay on one patient sample on an immulite 2000 xpi instrument. The initial result on the patient sample was below the analytical measurement range. The sample was repeated on the same instrument and the result was higher and acceptable to the customer. The initial result was not reported to the physician(s). It is unknown if the repeat result was 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 | 2247117-2016-00013 |
| MDR Report Key | 5477654 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-03 |
| Date of Report | 2016-02-19 |
| Date of Event | 2016-01-12 |
| Date Mfgr Received | 2016-02-19 |
| Date Added to Maude | 2016-03-03 |
| 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 | 2016-03-03 |
| 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 | 2016-03-03 |