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 2016-11-02 for BN II / BN PROSPEC? SYSTEM OSAR manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[58935545]
The cause of the falsely elevated igg results is unknown. Siemens healthcare headquarters support center and technical support laboratory representatives evaluated the data available. No systemic instrument or reagent issues were identified. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[58935546]
Falsely elevated immunoglobulin g (igg) results were obtained on two patient samples on the behring nephelometer ii (bn-ii) instrument. The patient results were not reported to the physician because the values exceeded the sum of the igg subclass determinations. The repeat test of the same samples on an alternate bnii instrument gave lower results consistent with the sum of the subclasses. The repeated results were reported to the physician. There is no indication of adverse impact to the patients due to the falsely elevated igg results, which were not reported to the physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2016-00030 |
| MDR Report Key | 6072324 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-02 |
| Date of Report | 2016-11-02 |
| Date of Event | 2016-09-01 |
| Date Mfgr Received | 2016-10-03 |
| Device Manufacturer Date | 2016-05-11 |
| Date Added to Maude | 2016-11-02 |
| 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 | 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 | 3 |
| Brand Name | BN II / BN PROSPEC? SYSTEM |
| Generic Name | N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) |
| Product Code | CFN |
| Date Received | 2016-11-02 |
| Catalog Number | OSAR |
| Lot Number | 153022D |
| Device Expiration Date | 2018-04-26 |
| 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 | 2016-11-02 |