MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-15 for BN II SYSTEM 10459300 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[123822307]
The customer contacted a siemens customer care center and reported that discordant, falsely elevated albumin results were intermittently obtained on patient samples on a bn ii system for a couple of weeks. However, the customer did not provide the data for the other patients impacted prior to (b)(6) 2018. The customer indicated that albumin was the only assay impacted by this issue and that re-calibrating the assay did not resolve the issue. A siemens customer service engineer was dispatched to the customer's site multiple times. During these visits, the cse: inspected the system performance during a precision run; adjusted the sample wash level; tightened the loose connections on brass valve 1; verified that wash was sufficiently delivered to cuvettes; replaced and aligned the sample probe; replaced dilutor valves, 2500 ul leaky syringe valve, 2/3 way solenoid valve, vacuum pump and two syringes; ran quality controls (qcs), precision tests and calibrations, which recovered acceptably. Siemens further analyzed the instrument files and did not find any issue with the calibration or qc data. The cause of the discordant, falsely elevated albumin results is unknown. The system is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[123822308]
Discordant, falsely elevated albumin results were obtained on two patient samples on a bn ii system. The discordant results were not reported to the physician(s). The samples were repeated on the same system twice, resulting lower. The 2nd repeat results 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 discordant, falsely elevated albumin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00106 |
| MDR Report Key | 7966906 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-15 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-09-20 |
| Date Mfgr Received | 2018-10-22 |
| Date Added to Maude | 2018-10-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | AM KRONBERGER HANG 3 REGISTRATION NUMBER:3003601075 |
| 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 | CIX |
| Date Received | 2018-10-15 |
| Model Number | BN II SYSTEM |
| Catalog Number | 10459300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-15 |
| Model Number | BN II SYSTEM |
| Catalog Number | 10459300 |
| 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 | 2018-10-15 |