MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-06-09 for IMMULITE 2000 manufactured by Siemens Healthcare Diagnostics Inc..
[22511138]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse performed a system decontamination and replaced the high speed spinner assembly. Upon revisit, the cse checked the tube lifter position and positioned it as per the specifications. The cause of the discordant thyroglobulin and androstenedione results on multiple patient samples is unknown.
Patient Sequence No: 1, Text Type: N, H10
[22511139]
Discordant thyroglobulin (tg) and androstenedione results were obtained on multiple patient samples on an immulite 2000 instrument. The discordant results were not reported to the physician(s). The samples were repeated twice on the same instrument for all the samples, except sample (b)(6) which was repeated three times. All the repeat results were as per clinician's expectations. It is unknown if the repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant thyroglobulin (tg) and androstenedione results.
Patient Sequence No: 1, Text Type: D, B5
[27576530]
Additional information (08/14/2015): a siemens headquarters support center (hsc) specialist reviewed the instrument data. Upon the hsc specialist's recommendations the customer reviewed their sample collection procedure. The customer modified the sample collection procedure and the issue resolved. The cause of the discordant thyroglobulin and androstenedione results on multiple patient samples is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[32034830]
The initial mdr 2247117-2015-000035 was filed on june 09, 2015. Additional information (06/23/2015): data was provided for two additional discordant thyroglobulin results. It is unknown if any of the results were reported to the physician(s).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2015-00035 |
| MDR Report Key | 4828534 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-06-09 |
| Date of Report | 2015-05-15 |
| Date of Event | 2015-05-12 |
| Date Mfgr Received | 2015-08-14 |
| Date Added to Maude | 2015-07-07 |
| 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 | MICHAEL METZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| 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 | CIZ |
| Date Received | 2015-06-09 |
| Model Number | IMMULITE 2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY ROAD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-09 |