MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for BN II SYSTEM 10801162 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[119790624]
The customer contacted a siemens customer care center and reported that a discordant, falsely elevated free light chains (flc), type kappa (flc kappa) result was obtained on a patient sample on the bn ii system. Siemens investigated the data provided by the customer and determined that the calibration curves on both systems were acceptable. The quality controls (qcs) on both systems recovered within acceptable ranges on the day of the event. There is no indication of an system or reagent malfunction as the acceptable results were obtained using the same reagent lot and system. The customer did not provide the system files for further investigation and the cause of the discordant, falsely elevated flc kappa result 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
[119790625]
A discordant, falsely elevated free light chains (flc), type kappa (flc kappa) result was obtained on a patient sample on a bn ii system. The discordant result was reported to the physician(s), who questioned the result. On the next day, the sample was repeated on the same system, resulting lower. The repeat result was reported, as the correct result, to the physician(s). On (b)(6) 2018, the sample was repeated on the same system and at an alternate laboratory. The 2nd repeat results and the results obtained at the alternate laboratory correlated with the repeat result obtained on (b)(6) 2018. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated flc kappa result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00084 |
| MDR Report Key | 7839622 |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-31 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2018-08-07 |
| Date Added to Maude | 2018-08-31 |
| 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 | 0 |
| Brand Name | BN II SYSTEM |
| Generic Name | BN II SYSTEM |
| Product Code | CFQ |
| Date Received | 2018-08-31 |
| Model Number | BN II SYSTEM |
| Catalog Number | 10801162 |
| 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- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-31 |