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 2017-10-19 for IMMULITE 2000 3GALLERGY SPECIFIC IGE manufactured by Siemens Healthcare Diagnostics Products, Limited.
[90672725]
The cause of the discordant, falsely low 3gallergy specific ige results for crab and shrimp on one patient sample is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[90672726]
The customer obtained discordant, falsely low 3gallergy specific ige results for crab (f23) and shrimp (f24) on a patient sample on an immulite 2000 xpi instrument, while using reagent lot 453. A new sample was obtained from the patient and was tested in an alternate laboratory on an alternate platform, resulting higher. The discordant results were reported to the physician(s). The corrected results from the alternate platform were reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low 3gallergy specific ige results for crab and shrimp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00558 |
| MDR Report Key | 6963933 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-19 |
| Date of Report | 2018-01-15 |
| Date of Event | 2017-07-03 |
| Date Mfgr Received | 2017-12-20 |
| Date Added to Maude | 2017-10-19 |
| 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 | 2017-10-19 |
| Model Number | IMMULITE 2000 3GALLERGY SPECIFIC IGE |
| Lot Number | 453 |
| 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 | 2017-10-19 |