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 2018-07-20 for BN PROSPEC SYSTEM 10465217 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[114547636]
The customer contacted siemens to report that they obtained a discordant, falsely elevated albumin result on the bn prospec system. A siemens customer service engineer (cse) and a regional support center (rsc) specialist were dispatched to the customer's site. The cse and rsc specialist decontaminated the system and replaced the wash station and a probe. Then, siemens ran a precision study with ten sample cups on the bn prospec system and the coefficient of variation (cv) recovered higher than the result obtained when the system was initially installed. In previous events at this customer's site, siemens determined that pre-analytical issues, including turbidity in samples, potentially contributed to the discordant, falsely elevated albumin recovery. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[114547637]
A discordant, falsely elevated albumin result was obtained on a patient sample on a bn prospec system. The discordant result was not reported to the physician(s). The sample was repeated twice on the same system, resulting lower. The lowest result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated albumin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00075 |
| MDR Report Key | 7705849 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-20 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-11-06 |
| Date Added to Maude | 2018-07-20 |
| 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 | RISK MANAGER |
| 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 PROSPEC SYSTEM |
| Generic Name | BN PROSPEC SYSTEM |
| Product Code | JZW |
| Date Received | 2018-07-20 |
| Model Number | BN PROSPEC SYSTEM |
| Catalog Number | 10465217 |
| 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 | 2018-07-20 |