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 2016-06-09 for IMMULITE manufactured by Siemens Healthcare Diagnostics Inc..
[47216093]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. The customer complained of tip jam errors and short samples. The cse evaluated the instrument and found that the probe tip was loose. The cse tightened the probe tip and lubricated and cleaned the pipettor mechanism. The cse ran level-sensing and pipette testing routines. The cse ran quality controls and adjustments, which were acceptable. The cause of the discordant, falsely low ue3 results on patient samples 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
[47216094]
Discordant, falsely low unconjugated estriol (ue3) results were obtained on patient samples on an immulite instrument. The customer provided one example of the discordant ue3 result. The discordant results were reported to the physician(s), except for sample id (b)(6). The samples were repeated on the same instrument, resulting as expected. The repeat result for sample id (b)(6) was reported to the physician(s). It is unknown if corrected results were reported to the physician(s) for the other patients. There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low ue3 results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2016-00032 |
| MDR Report Key | 5709793 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-06-09 |
| Date of Report | 2016-06-09 |
| Date of Event | 2016-04-18 |
| Date Mfgr Received | 2016-05-17 |
| Date Added to Maude | 2016-06-09 |
| 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 | 2016-06-09 |
| Model Number | IMMULITE |
| 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 RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-09 |