MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-28 for BN II SYSTEM 10462274 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[122463423]
The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely low albu result was obtained on a patient urine sample on the bn ii system. The customer indicated that there were no system errors at the time of the event. Additionally, quality controls were within expected ranges at the time of the event. The customer reported that the results obtained on the other urine samples tested for albumin, during the time period that the affected sample was initially tested, recovered acceptably. The customer deleted the instrument files required to investigate the cause of the discordant, falsely low albu result. The cause of the discordant result is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[122463424]
A discordant, falsely low albumin (albu) result was obtained on a patient urine sample on a bn ii system. The discordant result not reported to the physician(s). The sample was repeated on the same system, resulting higher. The repeat result was reported, as the correct result, to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low albu result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00100 |
| MDR Report Key | 7919082 |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-28 |
| Date of Event | 2018-08-17 |
| Date Mfgr Received | 2018-09-05 |
| Date Added to Maude | 2018-09-28 |
| 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 | 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 | CIX |
| Date Received | 2018-09-28 |
| Model Number | BN II SYSTEM |
| Catalog Number | 10462274 |
| 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 | 2018-09-28 |
| Model Number | BN II SYSTEM |
| Catalog Number | 10462274 |
| 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 | 2018-09-28 |