MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-23 for IMMULITE 2000 0300002 manufactured by Siemens Healthcare Diagnostics Inc..
[22122462]
A discordant low alpha-fetoprotein (afp) result was obtained for one (1) patient sample on an immulite 2000. The original result was sent to the physician, though was not reviewed by the physician before the repeat result was sent. The sample was re-tested and the repeat afp result was higher. Patient treatment was not altered or prescribed. There was no report of adverse health consequences due to the discordant afp result.
Patient Sequence No: 1, Text Type: D, B5
[22133117]
A siemens healthcare diagnostics inc. Fse (field service engineer) was sent to the customer site for instrument evaluation. After analysis of the system, the fse performed the 6 month pm and ran precision on afp. The cause of the discordant afp result could not be determined and no conclusion can be drawn as to what specifically corrected the problem. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2011-00036 |
| MDR Report Key | 2138570 |
| Report Source | 05,06 |
| Date Received | 2011-06-23 |
| Date of Report | 2011-05-25 |
| Date of Event | 2011-05-24 |
| Date Mfgr Received | 2011-05-25 |
| Date Added to Maude | 2012-05-07 |
| 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 ROAD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMUNO-ASSAY |
| Product Code | NSF |
| Date Received | 2011-06-23 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 0300002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-06-23 |