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..
[5110738]
The customer has obtained out of range values for quality control (qc) samples on the dehydroepiandrosterone sulfate (dhea-so4) assay on an immulite 2000 instrument. Patient sample values were reported to physician(s) despite qc levels 1 and 2 being out of range high, and qc level 3 being out of range low. Discordant (dhea-so4) results were obtained for four patient samples. The samples were repeated on same instrument for all four 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 dhea so4 results.
Patient Sequence No: 1, Text Type: D, B5
[12554662]
The customer contacted the siemens customer care center (ccc) and reported that quality control (qc) was out of 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 cause of discordant dhea so4 results is unknown. The cause of discordant patient results being reported to physician(s) while qc was out of range is a failure to follow instructions. As per the immulite 2000 dhea so4 instructions for use "use controls or serum pools with at least two levels (low and high) of dhea-so4". 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 | 2247117-2014-00078 |
| MDR Report Key | 4256384 |
| 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 |