MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-02-14 for IMMULITE 2000 030002 manufactured by Siemens Healthcare Diagnostics.
[1900743]
A discordant immulite 2000 gastrin result was obtained on a patient sample. The result was not reported to the physician. Upon retest the corrected result was reported to the physician. There were no reports of patient intervention or adverse health consequences due to the discordant gastrin result.
Patient Sequence No: 1, Text Type: D, B5
[8864801]
A siemens field service engineer (fse) was dispatched to the customer site. Analysis of the instrument and instrument data indicate that the cause for the discordant gastrin result was due to a misaligned dilution well bottom. The fse readjusted the dilution well and ran qc. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2011-00024 |
| MDR Report Key | 1987011 |
| Report Source | 05,06 |
| Date Received | 2011-02-14 |
| Date of Report | 2011-02-09 |
| Date of Event | 2011-02-07 |
| Date Mfgr Received | 2011-02-09 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2012-05-08 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVE |
| 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 | MA |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMUNOASSAY ANALYZER, PRODUCT CODE: |
| Product Code | DGC |
| Date Received | 2011-02-14 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 030002 |
| Lot 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 |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-14 |