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 2018-05-22 for IMMULITE 2000 3GALLERGY SPECIFIC IGE L2KUN6 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[109001045]
A siemens headquarters support center (hsc) specialist reviewed the kit release data for the latest lot (kit lot 602) available for immulite 2000 3gallergy specific ige results for rat epithelium allergen (e73), which showed that the allergen is performing as expected. The hsc specialist concluded that the potential cause of the discordant results could be due to the sample specific issue. The device is performing as expected. No further evaluation of device is required. Mdr 2432235-2018-00206 has been filed for the same event for allergen e87 which has different 510(k) # of k021206.
Patient Sequence No: 1, Text Type: N, H10
[109001046]
Discordant, false negative 3gallergy specific ige result for rat epithelium allergen (e73) (510 (k) # k013134) was obtained on one patient sample on an immulite 2000 xpi instrument, while using an unknown kit lot. The sample was also tested negative for rat allergen (e87) (510 (k) # k021206). The sample was repeated on an alternate platform for allergens e87 and e73, resulting positive. It is unknown which results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant 3gallergy specific ige results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00207 |
| MDR Report Key | 7533663 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-22 |
| Date of Report | 2018-07-20 |
| Date of Event | 2018-04-24 |
| Date Mfgr Received | 2018-06-04 |
| Date Added to Maude | 2018-05-22 |
| 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 | SHWETA GULATI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242870 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | UK REGISTRATION #: 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, GWYNEDD 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 3GALLERGY SPECIFIC IGE |
| Generic Name | IMMULITE 2000 3GALLERGY SPECIFIC IGE |
| Product Code | DHB |
| Date Received | 2018-05-22 |
| Model Number | IMMULITE 2000 3GALLERGY SPECIFIC IGE |
| Catalog Number | L2KUN6 |
| Lot Number | 601 |
| Device Expiration Date | 2019-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Address | GLYN RHONWY LLANBERIS GWYNEDD, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-22 |