MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-16 for IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT N/A C1L2/C2L2 manufactured by Siemens Healthcare Diagnostics.
[19870266]
Discordant false negative immulite 2000 xpi penicillin (c1 and c2) results were generated on one patient sample. The patient was first tested with a skin prick test with positive results. A sample was then tested on the immulite which gave negative results and when repeated they were slightly positive. The samples were then sent to a second laboratory where they tested positive. Several weeks later, a second sample was tested on the immulite 2000 xpi with negative results. Samples 1 and 2 were then sent to the swedish siemens allergy reference lab and both samples tested slightly positive. There was no known report of treatment given or withheld based on the discordant penicillin results.
Patient Sequence No: 1, Text Type: D, B5
[20280064]
A siemens global product support engineer analyzed the immulite 2000 xpi instrument data. Analysis of the instrument data indicates that the cause for the discordant penicillin c1 and c2 results is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2011-00200 |
| MDR Report Key | 2378471 |
| Report Source | 05,06 |
| Date Received | 2011-12-16 |
| Date of Report | 2011-12-05 |
| Date of Event | 2011-11-10 |
| Date Mfgr Received | 2011-12-05 |
| Date Added to Maude | 2012-07-25 |
| 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 | 2011-12-16 |
| Model Number | N/A |
| Catalog Number | C1L2/C2L2 |
| Lot Number | 344 |
| 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 | 2011-12-16 |