MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-16 for N ANTISERUM TO HUMAN ALBUMIN 10446283 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[142665873]
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 provided customer save data file. Siemens' analysis of the kinetic data from the complaint shows an increase in reactivity for the high sample result. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[142665874]
A discordant, falsely elevated albumin result was obtained on a (b)(6) female patient sample on the bn prospec system using n antiserum to human albumin lot 153939. The albumin was used for calculating csf/albumin serum ratio. The initial discordant, falsely elevated result was not reported to the physician(s). The sample was repeated on the same reagent and system and resulted in a lower value. There is no indication of a corrected report being issued to the physician(s). There is no known report 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 | 9610806-2019-00040 |
| MDR Report Key | 8517881 |
| Date Received | 2019-04-16 |
| Date of Report | 2019-06-27 |
| Date of Event | 2019-02-13 |
| Date Mfgr Received | 2019-05-28 |
| Date Added to Maude | 2019-04-16 |
| 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 | 0 |
| Brand Name | N ANTISERUM TO HUMAN ALBUMIN |
| Generic Name | N ANTISERUM TO HUMAN ALBUMIN |
| Product Code | DCF |
| Date Received | 2019-04-16 |
| Model Number | N ANTISERUM TO HUMAN ALBUMIN |
| Catalog Number | 10446283 |
| Lot Number | 153939E |
| 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 | 2019-04-16 |