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 2017-08-04 for IMMULITE 2000 WHITE ASH T15L2 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[81905032]
A siemens customer care center (ccc) specialist stated that the customer will be testing all samples on the a482 allergen in addition to the t15 allergen. The cause of the discordant false negative result with the t15 allergen is unknown. Siemens is investigating the issue. Mdr 2432235-2017-00461, mdr 2432235-2017-00463 and mdr 2432235-2017-00464 have been filed for the same issue.
Patient Sequence No: 1, Text Type: N, H10
[81905033]
A discordant, false negative result was obtained for t15 allergen (white ash allergen) with the immulite 2000 3gallergy specific ige assay on an immulite 2000 xpi instrument. The initial result was reported to physician(s), who questioned the result. The sample was re-tested with the immulite 2000 a482 allergen (nole e-1 allergen) on the same instrument and resulted positive. The sample was tested on an alternate platform with t25 allergen (ash tree allergen) and resulted positive. The repeat results were also provided to physician(s). There are no known reports of patient intervention due to the false negative t15 allergen result. There are no known reports of a delay in administering treatment or medical intervention to the patient due to the false negative t15 allergen result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00462 |
| MDR Report Key | 6768798 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-04 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-06-09 |
| Date Mfgr Received | 2017-09-27 |
| Date Added to Maude | 2017-08-04 |
| 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 WHITE ASH |
| Generic Name | IMMULITE 2000 WHITE ASH |
| Product Code | DHB |
| Date Received | 2017-08-04 |
| Model Number | IMMULITE 2000 WHITE ASH |
| Catalog Number | T15L2 |
| Lot Number | 601 |
| Device Expiration Date | 2019-02-28 |
| 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 | 2017-08-04 |