MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-09-04 for IMMULITE 2000 XPI manufactured by Siemens Healthcare Diagnostics.
[2928103]
Discordant, falsely low f17 allergen results were obtained on the immulite 2000 xpi instrument. It is unknown if the initial results were reported to the physician(s). There were no reports of patient intervention or adverse health consequences due to the discordant f17 allergen results.
Patient Sequence No: 1, Text Type: D, B5
[10102881]
A siemens field applications specialist (fas) evaluated the immulite 2000 xpi instrument and determined that there were no problems with the instrument. The cause of the discordant f17 allergen results is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00281 |
| MDR Report Key | 2724590 |
| Report Source | 05,06 |
| Date Received | 2012-09-04 |
| Date of Report | 2012-08-10 |
| Date of Event | 2012-08-10 |
| Date Mfgr Received | 2012-08-10 |
| Date Added to Maude | 2012-12-18 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MINDY LOSAPIO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242312 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | GLYN RHONWY LLANBERIS, CAERNARFON |
| Manufacturer City | GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 XPI |
| Generic Name | IMMULITE 2000 XPI HAZELNUT |
| Product Code | DHB |
| Date Received | 2012-09-04 |
| Model Number | IMMULITE 2000 XPI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | GLYN RHONWY LLANBERIS, CAERNARFON GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-04 |