MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-14 for IMMULITE 2000 manufactured by Siemens Healthcare Diagnostics, Inc..
[2364903]
Discordant, falsely high h. Pylori igg (hpg) results on multiple patient samples were generated on the immulite 2000. No results were reported. The patient samples were re-tested after assay adjustment and hpg results were generated that were lower than the initial results. There is no known report of adverse health consequences or patient intervention due to the discordant, falsely high hpg results.
Patient Sequence No: 1, Text Type: D, B5
[9384455]
A siemens field service engineer (fse) was dispatched to the customer site. After analysis of the instrument and instrument data, it was determined that the pattern of data indicated contamination. The cause of the contamination could not be determined. The fse decontaminated the substrate reservoir and water lines and proactively replaced parts in the substrate delivery line. It was determined that the cause of the discordant, falsely high hpg results was due to contamination. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2011-00067 |
| MDR Report Key | 2334332 |
| Report Source | 05,06 |
| Date Received | 2011-11-14 |
| Date of Report | 2011-10-18 |
| Date of Event | 2011-10-18 |
| Date Mfgr Received | 2011-10-18 |
| Date Added to Maude | 2012-05-31 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMULITE 2000 |
| Product Code | LYR |
| Date Received | 2011-11-14 |
| Model Number | IMMULITE 2000 |
| Lot Number | N/A |
| ID Number | N/A |
| 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 | 62 FLANDERS BARTLEY ROAD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-14 |