MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-04 for IMMULITE 2000 manufactured by Siemens Healthcare Diagnostics Inc..
[26488565]
The customer contacted a siemens customer care center (ccc) specialist. The customer was using an incorrect dilution factor for running the bmg assay. As per the immulite 2000 bmg instructions for use, the dilution factor for samples should be 1:40. Upon a siemens customer service engineer (cse) specialist's instructions, the customer corrected their dilution factor. The cause of the incorrect dilution factor being set on the instrument was related to the user error. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[26488566]
The operator of an immulite 2000 instrument had changed the dilution factor for beta-2 microglobulin (bmg) assay to 1:20. The customer ran the patient samples with an incorrect dilution factor. There are no known reports of patient intervention or adverse health consequences due to the incorrect dilution factor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2015-00049 |
| MDR Report Key | 5055958 |
| Date Received | 2015-09-04 |
| Date of Report | 2015-08-13 |
| Date of Event | 2015-08-13 |
| Date Mfgr Received | 2015-08-13 |
| Date Added to Maude | 2015-09-04 |
| 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 | MICHAEL METZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| 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 | 0 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMULITE 2000 |
| Product Code | JZG |
| Date Received | 2015-09-04 |
| 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 HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-04 |