MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-01-08 for IMMULITE 2000 manufactured by Siemens Healthcare Diagnostics Inc..
[35419445]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse found an issue with the water pump and replaced it. The cause of the discordant tsto, dhs, shbg, atpo, pylo, atg, hscrp, and hcy results on multiple patient samples was related to a faulty water pump. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[35419447]
The customer contacted the siemens customer care center (ccc) because discordant patient results were obtained on patient samples tested for multiple methods on an immulite 2000 instrument on (b)(6) 2015. The discordant results had been reported to the physician(s). The samples were repeated on an alternate immulite 2000 instrument and corrected results were reported to the physician(s). The customer also stated that discordant results had also been obtained on patient samples on (b)(6) 2015, but the results had not been reported to the physician(s) because quality controls (qc) were out of range. It is unknown if the corrected results were reported to the physician(s). Discordant results were obtained on the testosterone (tsto), dhea-so4 (dhs), sex hormone-binding globulin (shbg), anti-thyroid peroxidase antibodies (atpo), h. Pylori igg (pylo), autoantibodies to thyroglobulin (atg), high sensitive c-reactive protein (hscrp), and homocysteine (hcy). There are no known reports of patient intervention or adverse health consequences due to the discordant tsto, dhs, shbg, atpo, pylo, atg, hscrp, and hcy results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2016-00003 |
| MDR Report Key | 5354125 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-01-08 |
| Date of Report | 2015-12-14 |
| Date of Event | 2015-11-12 |
| Date Mfgr Received | 2015-12-14 |
| Date Added to Maude | 2016-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CASSADRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| 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 |
| Generic Name | IMMULITE 2000 |
| Product Code | CDZ |
| Date Received | 2016-01-08 |
| Model Number | IMMULITE 2000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| 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 | 2016-01-08 |