MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-02-04 for IMMULITE 2000 0300002 manufactured by Siemens Healthcare Diagnostics Inc..
[20938090]
A discordant low adrenocorticotropic hormone (acth) result was obtained for one (1) patient sample on an immulite 2000. The physician questioned the initial low result due to the patient's history. The sample was re-tested and the repeat acth result was high. Patient treatment was not altered or prescribed. There was no report of adverse health consequences due to the discordant acth result.
Patient Sequence No: 1, Text Type: D, B5
[21150357]
A siemens healthcare diagnostics inc. Fse (field service engineer) was sent to the customer site for instrument evaluation. After analysis of the system and system data, the fse replaced the sample probe, removed a bead from under the sample dispense area, and checked the sample carousel continuity. The actual cause 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 | 2247117-2011-00008 |
| MDR Report Key | 1979244 |
| Report Source | 06 |
| Date Received | 2011-02-04 |
| Date of Report | 2011-01-14 |
| Date of Event | 2011-01-14 |
| Date Mfgr Received | 2011-01-14 |
| Date Added to Maude | 2012-05-10 |
| 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 | OT |
| 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 | DGC |
| Date Received | 2011-02-04 |
| 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 | 2011-02-04 |