MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-09 for IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT N/A ALLERGEN F10 manufactured by Siemens Healthcare Diagnostics.
[2330596]
False negative immulite 2000 f10 (sesame seed) allergen results were generated on three patient samples. The laboratory reran the samples on a second instrument for confirmation. All repeat results were positive. There was no known report of treatment given or withheld based on the discordant.
Patient Sequence No: 1, Text Type: D, B5
[9595705]
A siemens technical support specialist analyzed the immulite 2000 instrument data. Analysis of the instrument data indicates that the cause for the discordant. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00001 |
| MDR Report Key | 2403594 |
| Report Source | 05,06 |
| Date Received | 2012-01-09 |
| Date of Report | 2011-12-15 |
| Date of Event | 2011-12-15 |
| Date Mfgr Received | 2011-12-15 |
| Date Added to Maude | 2012-07-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | GLYN RHONWY LLANBERIS |
| Manufacturer City | CAERNAFON, GWYNEDD,, WALES 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 UNIVERSAL KIT |
| Generic Name | 3GALLERGY SPECIFIC IGE |
| Product Code | DHB |
| Date Received | 2012-01-09 |
| Model Number | N/A |
| Catalog Number | ALLERGEN F10 |
| Lot Number | 202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | GLYN RHONWY LANNBERIS CAERNAFON, GWYNEDD,, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-09 |