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 2019-04-24 for N ANTISERUM TO HUMAN ALBUMIN 10446283 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[143988968]
The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely elevated albumin result was obtained on a patient sample on the bn prospec system. Siemens analyzed the submitted data file, system logs and the instrument service history and determined there was no evidence of instrument malfunction. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[143988969]
A discordant, falsely elevated albumin/cerebrospinal fluid (csf) result was obtained using n antiserum to human albumin lot 153936e on the bn prospec system. The albumin was used for calculating csf/albumin serum ratio. The initial falsely elevated result was not reported to the physician(s). The initial sample was repeated using the same instrument and reagent and resulted in a lower value. A second repeat was performed to confirm the lower obtained result and it also resulted lower. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated albumin csf results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00045 |
| MDR Report Key | 8545765 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-24 |
| Date of Report | 2019-06-27 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-05-28 |
| Date Added to Maude | 2019-04-24 |
| 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 | MR. BENLEY SAINT-JEAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10951 |
| Manufacturer Country | US |
| Manufacturer Postal | 10951 |
| Manufacturer Phone | 9145242398 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING-STR. 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 9610806-2019/06/28-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N ANTISERUM TO HUMAN ALBUMIN |
| Generic Name | N ANTISERUM TO HUMAN ALBUMIN |
| Product Code | DCF |
| Date Received | 2019-04-24 |
| Model Number | N ANTISERUM TO HUMAN ALBUMIN |
| Catalog Number | 10446283 |
| Lot Number | 153936E |
| 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 | 2019-04-24 |