MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-11-10 for IMMULITE 2000 XPI 030001-3 manufactured by Siemens Healthcare Diagnostics Inc..
[30867424]
A siemens technical assay specialist (tas) was dispatched to the customer site. The tas worked with the customer, and ran hcg calibration verification material (cvm) for assay linearity, quality control samples, and patient samples provided by the customer. As the customer had two immulite 2000 xpi's the study was carried out on both instruments, and the results on both instruments were within specifications. The cause of the discordant hcg results 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
[30867545]
The customer has obtained discordant results on patient samples for the human chorionic gonadotropin (hcg) assay on an immulite 2000 xpi instrument. The customer indicated that the results were discordant at the low end of the assay <5 iu/ml and at the high end. The discordant results were not reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant results obtained on the immulite 2000 xpi.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2015-00062 |
| MDR Report Key | 5213678 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-11-10 |
| Date of Report | 2015-10-16 |
| Date of Event | 2015-10-16 |
| Date Mfgr Received | 2015-10-16 |
| Date Added to Maude | 2015-11-10 |
| 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 | 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 | JJQ |
| Date Received | 2015-11-10 |
| Model Number | IMMULITE 2000 XPI |
| Catalog Number | 030001-3 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| 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 | 2015-11-10 |