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 2018-05-29 for IMMULITE 2000 3GALLERGY SPECIFIC IGE L2KUN6 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[110050695]
A siemens headquarter support center (hsc) specialist reviewed the kit release data for immulite 2000 e2 (dog epithelium) allergen lot 602. The release data indicates that the allergen is performing as expected. The issue appears to be a possible sampling issue with the system or a sample specific issue. There is no more sample available of the original sample for repeat testing or troubleshooting. A re-draw from the patient has been requested. The cause of the discordant, false negative result on the immulite 2000 xpi 3gallergy specific ige for e2 (dog epithelium) allergen is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[110050696]
A discordant, false negative result was obtained on the immulite 2000 xpi 3gallergy specific ige for e2 (dog epithelium; ref (b)(4); 510(k) # k013134) allergen. The test was ordered by the patient's mother and the result was reported to the patient. The same sample was also tested on an alternate method with the euroimmun allergen panel (inhalant panel and includes e2 allergen) and resulted positive. There are no known reports of patient intervention due to the false negative result on the immulite 2000 xpi 3gallergy specific ige for e2 allergen. There are no known reports of a delay in administering treatment or medical intervention to the patient due to the false negative result on the immulite 2000 xpi 3gallergy specific ige for e2 allergen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00226 |
| MDR Report Key | 7550925 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-29 |
| Date of Report | 2018-07-23 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-06-29 |
| Date Added to Maude | 2018-05-29 |
| 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 | DEVYANI CHAUDHURI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242637 |
| 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 | 2018-05-29 |
| Model Number | IMMULITE 2000 3GALLERGY SPECIFIC IGE |
| Catalog Number | L2KUN6 |
| Lot Number | 483 |
| Device Expiration Date | 2018-09-30 |
| 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 | 2018-05-29 |