MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-08 for IMMULITE 2000 manufactured by Siemens Healthcare Diagnostics Inc..
[35761839]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse replaced the sample probe and the dual resolution dilutor (drd). The cse performed precision testing, which was acceptable. The cause of the discordant, falsely low igf-1 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
[35761840]
Discordant, falsely low insulin-like growth factor 1 (igf-1) results were obtained on multiple patient samples on an immulite 2000 instrument. The discordant results were reported to the physician(s), who questioned them. The samples were repeated on the same instrument, resulting higher. It is unknown if the corrected results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low igf-1 results.
Patient Sequence No: 1, Text Type: D, B5
[37538098]
The initial mdr 2247117-2016-00004 was filed on january 08, 2016. Corrected information (02/01/2016): mdr 2247117-2016-00004 was filed with a date of 12/15/2015. The correct date is 12/04/2015. This has been corrected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2016-00004 |
| MDR Report Key | 5353626 |
| Date Received | 2016-01-08 |
| Date of Report | 2015-12-04 |
| Date of Event | 2015-11-11 |
| Date Mfgr Received | 2015-12-04 |
| 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 | 3 |
| 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 | CASSANDRA 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 | CFL |
| Date Received | 2016-01-08 |
| Model Number | IMMULITE 2000 |
| Operator | HEALTH PROFESSIONAL |
| 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 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMULITE 2000 |
| Product Code | DGC |
| Date Received | 2016-01-08 |
| Model Number | IMMULITE 2000 |
| 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 | 2016-01-08 |