MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N ANTISERUM TO HUMAN ALBUMIN

Model Number N ANTISERUM TO HUMAN ALBUMIN

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2019-00040 on 16-apr-2019.Additional information (28-may-2019): siemens healthcare diagnostics has confirmed that discordant, falsely elevated albumin results may be obtained on bn prospec systems when samples are processed using n cuvette segments manufactured using a certain mold.Siemens determined that discordant, falsely elevated albumin results are only obtained under specific laboratory setups (for example, a certain combination of other tests in use, measurement scenario, throughput) in combination with the usage of certain n cuvette segments.Urgent medical device correction (umdc) pp-19-002.A.Us was sent to us customers in june-2019 and customer notification (cn) pp-19-002_a ous was sent to outside the us (ous) customers in may-2019.The umdc and cn indicate that unexpected elevated albumin results may be obtained on the bn prospec system under certain conditions.The umdc indicates that the n cuvette segments produced since march 2019 (first lot 190790049) are available and in distribution and will eliminate the issue.The customers were instructed to contact siemens customer care center if they obtain increased discordant, falsely elevated albumin results.The result code and conclusion code in section h6 were updated to reflect the additional information.

• Brand Name: N ANTISERUM TO HUMAN ALBUMIN
• Type of Device: N ANTISERUM TO HUMAN ALBUMIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 8517881
• MDR Text Key: 142665873
• Report Number: 9610806-2019-00040
• Device Sequence Number: 1
• Product Code: DCF
• Combination Product (y/n): N
• PMA/PMN Number: K972929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2020
• Device Model Number: N ANTISERUM TO HUMAN ALBUMIN
• Device Catalogue Number: 10446283
• Device Lot Number: 153939E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 9610806-2019/06/28-001-C
• Patient Sequence Number: 1
• Patient Age: 22 YR