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 2015-12-29 for IMMULITE 2000 manufactured by Siemens Healtchcare Diagnostics Inc.
[34612478]
A siemens customer service engineer (cse) was dispatched to the customer. After evaluation of the instrument and instrument data, the cse performed a total service check. The cse discovered the sample probe tip was covered with gel like material, and replaced it. The cse ran a water test, precision testing with the two samples in question, and precision testing on quality controls, and results were within range. The cse and the technical applications specialist performed a 300 replicate precision testing on the estradiol method, which resulted with no outliers. The cause of the discordant progesterone and estradiol results was related to gel buildup on the sample probe tip. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[34612479]
Discordant progesterone and estradiol results were obtained on two 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, and the results matched the patients' clinical history. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant progesterone and estradiol results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2015-00065 |
| MDR Report Key | 5332727 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-12-29 |
| Date of Report | 2015-12-07 |
| Date of Event | 2015-12-05 |
| Date Mfgr Received | 2015-12-07 |
| Date Added to Maude | 2015-12-29 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 62 FLANDERS BARTLEY RD |
| 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 | JLX |
| Date Received | 2015-12-29 |
| 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 HEALTCHCARE DIAGNOSTICS INC |
| Manufacturer Address | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-29 |