MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-25 for BN II SYSTEM OVIA11 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[58614944]
A siemens field service engineer (fse) was dispatched to the customer site on 2016-09-29. Per the fse report, the cause of the discrepant igg results is related to a leak that occurred around the connection of the sample probe tubing. The fse cleaned the connection and replaced the tubing. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[58614945]
Three discrepant igg patient results were obtained on a bnii instrument. The patient results were reported to the physician. The physician(s) questioned the results. The samples were repeated on an alternate bnii instrument and higher results were obtained. Patient treatment was not altered or prescribed based on the initial igg results. There is no indication of any adverse health consequences due to the initial igg results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2016-00029 |
| MDR Report Key | 6053867 |
| Date Received | 2016-10-25 |
| Date of Report | 2016-10-25 |
| Date of Event | 2016-09-21 |
| Date Mfgr Received | 2016-09-26 |
| Date Added to Maude | 2016-10-25 |
| 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 | EDWARD SZYMANSKI |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026317672 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | 76 EMIL VON BEHRING STRASSE |
| Manufacturer City | MARBURG, 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BN II SYSTEM |
| Generic Name | BN II |
| Product Code | DEW |
| Date Received | 2016-10-25 |
| Catalog Number | OVIA11 |
| 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 | 76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-25 |