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 2014-11-10 for IMMULITE 2000 30002 manufactured by Siemens Healthcare Diagnostics Inc..
[5015806]
A discordant, falsely elevated calcitonin result was obtained on one patient sample on an immulite 2000 instrument. The falsely elevated calcitonin result was not reported to the physician(s). The same sample was repeated on the same instrument and resulted lower than the initial result. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated calcitonin result.
Patient Sequence No: 1, Text Type: D, B5
[12462012]
The customer ran quality controls (qc) before the discordant result was obtained. The qc was in range for all three levels. A siemens field service engineer (fse) was dispatched to the customer's site. The fse evaluated the instrument and discovered a broken tube lifter. The fse replaced the tube lifter and adjusted the turnaround number for the wash station and dilution station. The cause of discordant calcitonin result is unknown. 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 | 2247117-2014-00070 |
| MDR Report Key | 4241104 |
| Report Source | 01,05,06 |
| Date Received | 2014-11-10 |
| Date of Report | 2014-10-17 |
| Date of Event | 2014-10-09 |
| Date Mfgr Received | 2014-10-17 |
| Date Added to Maude | 2014-11-21 |
| 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 AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242678 |
| 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 | JKR |
| Date Received | 2014-11-10 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 30002 |
| 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 ROAD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-10 |