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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2023

Event Type  malfunction  

Event Description

A falsely elevated albumin result was obtained on a cerebrospinal fluid (csf) patient sample on a bn prospec system using n antiserum to human albumin reagent.The erroneous result was reported to the physician(s) and was questioned.On (b)(6) 2023, the sample was repeated on the same instrument for albumin csf, recovering lower.The lower 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 falsely elevated albumin result.

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse checked the probes, tubing, and syringes and did not detect any issues.The cse also cleaned a probe and the customer performed weekly maintenance.Furthermore, a system decontamination was performed.There is no evidence that a reagent or instrument contributed to the falsely elevated result.Quality controls recovered within acceptable ranges and no issues were reported with other patient samples.The calibration curve and the mean deviation were acceptable.A sample integrity issue contributed to the falsely elevated albumin result.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 17371406
• MDR Text Key: 320380029
• Report Number: 9610806-2023-00010
• Device Sequence Number: 1
• Product Code: DCF
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K972929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2024
• Device Model Number: N ANTISERUM TO HUMAN ALBUMIN
• Device Catalogue Number: 10446283
• Device Lot Number: 153968A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female