MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-12-17 for IMMULITE 2000 030002 manufactured by Siemens Healthcare Diagnostics, Inc..
[1750330]
Discordant nonreactive (negative) immulite 2000 allergen test results were obtained on one pt sample. Repeat testing and a new sample draw showed consistent results. Pt suffered and was treated for anaphylactic shock (prior to surgery) after the administration of antibiotics. When tested on a different system, the results were reactive (positive).
Patient Sequence No: 1, Text Type: D, B5
[8810594]
A siemens healthcare technical service engineer (tse) evaluated the immulite 2000 instrument data. Analysis of the instrument data indicate that there were no issues found in the files and the cause for the false negative allergen test results is unk. The instrument is performing within specifications. No further eval of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2010-00056 |
| MDR Report Key | 1940962 |
| Report Source | 05,06 |
| Date Received | 2010-12-17 |
| Date of Report | 2010-11-18 |
| Date of Event | 2010-10-05 |
| Date Mfgr Received | 2010-11-18 |
| Date Added to Maude | 2011-01-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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, INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY RD. |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMUNO-ASSAY |
| Product Code | DGC |
| Date Received | 2010-12-17 |
| Model Number | NA |
| Catalog Number | 030002 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | FLANDERS NJ 07835 US 07835 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-17 |