MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-17 for IMMULITE 2000 30002 manufactured by Siemens Healthcare Diagnostics Inc..
[5110220]
Discordant thyroxine binding globulin (tbg) results were obtained for two patient samples on an immulite 2000 instrument. The initial discordant results were reported to the physician(s). The samples were repeated on same instrument for both patients and corrected results were obtained. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant tbg results.
Patient Sequence No: 1, Text Type: D, B5
[12466154]
The customer contacted the siemens customer care center (ccc) and reported that on the day discordant results were obtained, one result for quality control (qc) sample was out of range and was repeated in range. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse evaluated the instrument and installed preventive maintenance kit. The cse also ran decontamination on the water pump, wash probe tubing and substrate tower and heater. Cse ran water test and qc. The qc was in range after adjustments performed. The cause of discordant tbg results 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
| Report Number | 2247117-2014-00079 |
| MDR Report Key | 4256367 |
| Report Source | 05,06 |
| Date Received | 2014-11-17 |
| Date of Report | 2014-10-23 |
| Date of Event | 2014-10-13 |
| Date Mfgr Received | 2014-10-23 |
| Date Added to Maude | 2014-11-28 |
| 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 | JJQ |
| Date Received | 2014-11-17 |
| 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 | 2014-11-17 |