MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-12-19 for IMMULITE 2000 XPI 030001-03 manufactured by Siemens Healthcare Diagnostics Inc..
[5141687]
A discordant total human chorionic gonadotropin (thcg) result was obtained on one patient sample on an immulite 2000 xpi instrument. The discordant result was reported to the physician(s). The sample was repeated on the same system. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant thcg result.
Patient Sequence No: 1, Text Type: D, B5
[12700242]
The siemens headquarters support center (hsc) was contacted by the customer. The hsc evaluated the instrument data and determined that there was a 25 millimeter difference between the first pipetting of the sample and the second pipetting. The hsc also determined that the system displayed a sample pipettor error during the time of the event. The cause of the discordant thcg result is unknown. The customer successfully repeated the thcg result. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2014-00091 |
| MDR Report Key | 4348631 |
| Report Source | 01,05,06 |
| Date Received | 2014-12-19 |
| Date of Report | 2014-11-24 |
| Date of Event | 2014-11-20 |
| Date Mfgr Received | 2014-11-24 |
| Date Added to Maude | 2015-01-06 |
| 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 | JOHN NELSON |
| Manufacturer Street | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY RD |
| 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 XPI |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJQ |
| Date Received | 2014-12-19 |
| Model Number | IMMULITE 2000 XPI |
| Catalog Number | 030001-03 |
| 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 RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-19 |