MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-21 for IMMULITE 2000 N/A 0300002 manufactured by Siemens Healthcare Diagnostics.
[2123571]
A discordant (b)(6) immulite 2000 hbsag result was generated on one patient sample. The sample was repeated in duplicate confirming (b)(6) result, which was reported to the physician. The physician requested that the sample be tested at another lab for (b)(6) which then generated a (b)(6) result. There was no known report of treatment given or withheld based on the discordant hbsag results.
Patient Sequence No: 1, Text Type: D, B5
[9209066]
A siemens fse (field service engineer) analyzed the immulite 2000 instrument and instrument data. After analyzing the instrument and instrument data the fse ran a qc precision test. The instrument is performing within specifications. The cause of the (b)(6) hbsag result is unknown. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2011-00043 |
| MDR Report Key | 2170600 |
| Report Source | 05,06 |
| Date Received | 2011-07-21 |
| Date of Report | 2011-06-27 |
| Date of Event | 2011-06-05 |
| Date Mfgr Received | 2011-06-27 |
| Date Added to Maude | 2011-11-02 |
| 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 | IMMUNO-ASSAY |
| Product Code | DGC |
| Date Received | 2011-07-21 |
| Model Number | N/A |
| 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 |
| Manufacturer Address | FLANDERS NJ 07835 US 07835 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-21 |