MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-10-12 for IMMULITE 2000 030002 manufactured by Siemens Healthcare Diagnostics Inc..
[1836687]
A discordant low immulite 2000 ca15-3 result was obtained for one (1) pt sample. The physician questioned the result due to the pt's history, and the sample was re-tested. Pt treatment was not altered or prescribed. There was no report of adverse health consequences due to the discordant ca15-3 results.
Patient Sequence No: 1, Text Type: D, B5
[8769576]
A siemens healthcare technical service engineer (tse) evaluated the immulite 2000 instrument data. The tse concluded that the cause of the discrepant ca15-3 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 | 2247117-2010-00043 |
| MDR Report Key | 1874233 |
| Report Source | 05,06 |
| Date Received | 2010-10-12 |
| Date of Report | 2010-09-27 |
| Date of Event | 2010-09-22 |
| Date Mfgr Received | 2010-09-27 |
| Date Added to Maude | 2012-02-28 |
| 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 AVE |
| 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 | 2010-10-12 |
| 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 | 2010-10-12 |