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 2014-11-14 for IMMULITE 2000 XPI 030001-03 manufactured by Siemens Healthcare Diagnostics Inc..
[5110650]
Discordant, falsely elevated thyroglobulin (tg) results were obtained on two patient samples on an immulite 2000 xpi instrument. The falsely elevated tg results were reported to the physician(s) who questioned them. The new samples were drawn for both patients and tested on the same instrument for sid # (b)(6) and on an alternate immulite 2000 xpi instrument for sid # (b)(6). Both patient samples resulted lower than the initial results. Both patient samples were then tested in alternate labs, also resulting lower than the initial results. It is unknown if the corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tg results.
Patient Sequence No: 1, Text Type: D, B5
[12551411]
The cause of falsely elevated thyroglobulin results is unknown. Siemens healthcare diagnostics is investigating the issue
Patient Sequence No: 1, Text Type: N, H10
[35267690]
The initial mdr 2247117-2014-00074 was filed on november 14, 2014. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37766710]
The initial mdr 2247117-2014-00074 was filed on november 14, 2014. The first supplemental mdr 2247117-2014-00074_s1 was filed on november 25, 2014. Additional information (12/12/2014): a precision study was performed on the instrument and the percentage coefficient of variation was acceptable. The cause of the discordant thyroglobulin results is unknown. Additional information (12/16/2014): no further discordant results have been obtained on this instrument. This instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2014-00074 |
| MDR Report Key | 4252224 |
| Report Source | 01,05,06 |
| Date Received | 2014-11-14 |
| Date of Report | 2014-10-22 |
| Date of Event | 2014-07-31 |
| Date Mfgr Received | 2014-12-12 |
| Date Added to Maude | 2014-11-25 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 XPI |
| Generic Name | IMMULITE 2000 XPI |
| Product Code | JJQ |
| Date Received | 2014-11-14 |
| Model Number | IMMULITE 2000 XPI |
| Catalog Number | 030001-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-11-14 |