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 2019-05-02 for BN II SYSTEM 10462274 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[143989082]
The customer contacted a siemens customer care center (ccc) and reported that the bn ii system released incorrect free light chains, type kappa (flc kappa) results to a non-siemens host. Siemens analyzed the submitted data file and system logs file; no similar occurrences have been reported from the customer prior to and post the event. The use of the non-siemens reagent on the bn ii system is not validated by siemens (off-label). Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[143989083]
A customer reported that incorrect free light chains, type kappa (flc kappa) results (with technical flags) were released by the bn ii system for two patient samples to a non-siemens host. The results were obtained using a non-siemens reagent on the bn ii system. The results were not released to the physician(s). Both samples were rerun with multiple higher dilutions on the same instrument and higher results were obtained on the samples. The results obtained using the 1:2000 dilution were reported, as the correct results, to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the incorrect results released by the bn ii system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00046 |
| MDR Report Key | 8575434 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-05-10 |
| Date Added to Maude | 2019-05-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BENLEY SAINT-JEAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242398 |
| Manufacturer G1 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | REGISTRATION NUMBER:3003601075 AM KRONBERGER HANG 3 |
| Manufacturer City | SCHWALBACH, 65824 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BN II SYSTEM |
| Generic Name | BN II SYSTEM |
| Product Code | DFH |
| Date Received | 2019-05-02 |
| Model Number | BN II SYSTEM |
| Catalog Number | 10462274 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041 |
| Brand Name | BN II SYSTEM |
| Generic Name | BN II SYSTEM |
| Product Code | JQX |
| Date Received | 2019-05-02 |
| Model Number | BN II SYSTEM |
| Catalog Number | 10462274 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-02 |