MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-14 for IMMULITE 2000 10380062 manufactured by Siemens Healthcare Diagnostics Inc..
[20794072]
A discordant low gastrin (gas) result was obtained for one (1) patient sample on an immulite 2000. The laboratory questioned the initial low result and the sample was re-tested twice. The repeat gas results were higher and were reported. The discordant result was not reported to the physician. Patient treatment was not altered or prescribed. There was no report of adverse health consequences due to the discordant gas result.
Patient Sequence No: 1, Text Type: D, B5
[20905160]
A siemens healthcare diagnostics inc. Fse (field service engineer) was sent to the customer site. The fse completed an inspection which included checking dispense volumes, spinner speeds (both wash and dilution well), temperatures and sample and reagent pipettor positions. The fse also ran a precision run on gastrin using all three levels of controls. The precision results were within specifications. After analysis of the system and system data, the actual cause could not be determined and no conclusion can be drawn as to what specifically caused the problem. The instrument is performing within specifications and no further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2011-00041 |
| MDR Report Key | 2162539 |
| Report Source | 05,06 |
| Date Received | 2011-07-14 |
| Date of Report | 2011-06-16 |
| Date of Event | 2011-06-09 |
| Date Mfgr Received | 2011-06-16 |
| Date Added to Maude | 2011-10-05 |
| 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 | DGC |
| Date Received | 2011-07-14 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 10380062 |
| 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 | 2011-07-14 |