MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-12-15 for BN PROSPEC? SYSTEM SMN10461865 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[62471911]
The cause of the discordant low n latex flc result is unknown. Siemens headquarters support center evaluated the data files provided by the account. The account provided data files but not the correct files for the sample id in question. Because of the lack of information, no root-cause could be identified.
Patient Sequence No: 1, Text Type: N, H10
[62471912]
A discordant low n latex flc lambda result was obtained on a patient sample on the bn prospec instrument. The result was reported to the physician who questioned the result. The same sample was repeated on the same instrument and a higher result was obtained. A corrected result was reported. There is no indication that patient treatment was altered or prescribed on the basis of the discordant low n latex flc lambda result. There was no report of adverse health consequences as a result of the discordant low n latex flc lambda result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2016-00045 |
| MDR Report Key | 6177307 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-15 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-11-17 |
| Date Mfgr Received | 2016-11-17 |
| Date Added to Maude | 2016-12-15 |
| 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 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 | 3 |
| Brand Name | BN PROSPEC? SYSTEM |
| Generic Name | BN PROSPEC? SYSTEM, |
| Product Code | JZW |
| Date Received | 2016-12-15 |
| Model Number | BN PROSPEC |
| Catalog Number | SMN10461865 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-12-15 |