MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-06 for IMMULITE 2000 N/A 030002 manufactured by Siemens Healthcare Diagnostics.
[1886462]
Three discordant low immulite 2000 hcg results and one ue3 result was obtained on three (3) patient samples. The laboratory repeated the samples and the repeat results were reported to the physician(s). There was no report of treatment given or withheld based on the discordant hcg and ue3 results.
Patient Sequence No: 1, Text Type: D, B5
[9177484]
A siemens fse (field service engineer) analyzed the immulite 2000 instrument and instrument data. Analysis of the instrument and instrument data indicates that the cause for the discordant hcg and ue3 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 | 2247117-2011-00019 |
| MDR Report Key | 2042501 |
| Report Source | 05,06 |
| Date Received | 2011-04-06 |
| Date of Report | 2011-03-16 |
| Date of Event | 2011-03-16 |
| Date Mfgr Received | 2011-03-16 |
| Date Added to Maude | 2012-02-23 |
| 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 | 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMUNO-ASSAY |
| Product Code | DGC |
| Date Received | 2011-04-06 |
| Model Number | N/A |
| Catalog Number | 030002 |
| 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 | FLANDERS NJ 07835 US 07835 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-06 |