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 2017-12-04 for IMMULITE 2000 3GALLERGY SPECIFIC IGE manufactured by Siemens Healthcare Diagnostics Products, Limited.
[94795934]
The customer contacted a siemens customer care center. System calibration and quality controls were within acceptable ranges. The kit status was overdue while running the sample in question. The cause of the discordant, false negative 3gallergy specific ige results for fp5 panel on two patient samples is unknown. Siemens is investigating the issue. Mdrs 2432235-2017-00628 and 2432235-2017-00630 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[94795935]
Discordant, false negative results were obtained for 3gallergy specific ige for food panel 5 (fp5) on one patient sample upon initial and repeat testing, while using kit lot 602. The discordant results were not reported to the physician(s). The sample was sent to an alternate laboratory, where it was tested on an unknown platform, resulting positive. It is unknown if the result from alternate laboratory was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, false negative 3gallergy specific ige results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00629 |
| MDR Report Key | 7080215 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-04 |
| Date of Report | 2018-04-06 |
| Date of Event | 2017-11-08 |
| Date Mfgr Received | 2018-03-13 |
| Date Added to Maude | 2017-12-04 |
| 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 | 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 | 2017-12-04 |
| Model Number | IMMULITE 2000 3GALLERGY SPECIFIC IGE |
| Lot Number | 602 |
| 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 | 2017-12-04 |