MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for BN II SYSTEM SMN 10454733 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[67250141]
The cause of the imprecise replicate iggc results is unknown. A siemens field service engineer was dispatched to the site and was not able to reproduce the imprecision. Instrument probes were replaced proactively and precision studies were acceptable. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[67250142]
Imprecise replicate immunoglobulin g (iggc) results were obtained on a patient cerebrospinal fluid (csf) sample on the bnii system. It is unknown if results were reported to the physician. There are no known reports of patient intervention or adverse health consequences due to the imprecise replicate iggc results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00020 |
| MDR Report Key | 6312825 |
| Date Received | 2017-02-08 |
| Date of Report | 2017-02-08 |
| Date of Event | 2016-12-14 |
| Date Mfgr Received | 2017-01-09 |
| Date Added to Maude | 2017-02-08 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BN II SYSTEM |
| Generic Name | BN II SYSTEM |
| Product Code | DEW |
| Date Received | 2017-02-08 |
| Model Number | BN II SYSTEM |
| Catalog Number | SMN 10454733 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL VON BEHRING STRASSE 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-08 |