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 2017-02-15 for BN PROSPEC ANALYZER SMN 10461865 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[67500449]
The cause of the discordant low csf albumin results is an incorrect probe alignment. A siemens healthcare field service engineer was dispatched to the account. During instrument maintenance an incorrect probe alignment was identified and immediately corrected. After the bn prospec maintenance was performed there were no further discrepant results observed by the customer. Siemens headquarters support center representative evaluated the quality control data from the time of the incident and noted that qc had been within laboratory ranges. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[67500450]
Discordant low albumin results were obtained on cerebrospinal fluid (csf) patient samples on the bn prospec instrument. Results were reported to the physician(s). The same samples were repeated and higher results were obtained. Corrected reports were issued. There are no reports of patient intervention or adverse health consequences as a result of the discordant low albumin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00022 |
| MDR Report Key | 6332103 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-15 |
| Date of Report | 2017-02-15 |
| Date of Event | 2017-01-11 |
| Date Mfgr Received | 2017-01-16 |
| Date Added to Maude | 2017-02-15 |
| 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 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 | 3 |
| Brand Name | BN PROSPEC ANALYZER |
| Generic Name | BN PROSPEC ANALYZER |
| Product Code | JZW |
| Date Received | 2017-02-15 |
| Catalog Number | SMN 10461865 |
| 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 | 2017-02-15 |