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 2017-02-02 for IMMULITE manufactured by Siemens Healthcare Diagnostics Inc..
[66450997]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse determined that the instrument had ongoing syringe errors. The cse replaced the syringe pump and the issue resolved. A siemens headquarters support center (hsc) specialist reviewed the service report and stated that the faulty syringe pump may have caused the discordant results due to the inaccurate dispense and aspiration volumes. Quality controls and patient samples have been running as expected after the troubleshooting was performed by the cse. The cause of the discordant progesterone results on two patient samples is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[66450998]
Discordant progesterone results were obtained on two patient samples on an immulite instrument. The samples were repeated twice on the same instrument, resulting higher on the first repeat and lower on the second repeat run. All results were reported to the physician(s), who questioned them. The physician(s) accepted the higher progesterone results for both patients. There are no known reports of patient intervention or adverse health consequences due to the discordant progesterone results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2017-00011 |
| MDR Report Key | 6298022 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-02 |
| Date of Report | 2017-02-02 |
| Date of Event | 2017-01-08 |
| Date Mfgr Received | 2017-01-09 |
| Date Added to Maude | 2017-02-02 |
| 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 |
| Generic Name | IMMULITE |
| Product Code | JJQ |
| Date Received | 2017-02-02 |
| Model Number | IMMULITE |
| 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 RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-02 |