MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N ANTISERUM TO HUMAN-IG/L-CHAIN, TYPE KAPPA

Model Number N ANTISERUM TO HUMAN-IG/L-CHAIN, TYPE KAPPA

Device Problem Low Test Results (2458)

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

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that two discordant, falsely low ig/l-chain, type kappa results were obtained on two patient serum samples on a bn ii system using n antiserum to human-ig/l-chain, type kappa reagent.Quality controls (qc) recovered within range on the day the discordant results were obtained.The customer sent siemens the bn ii system log files for further investigation.Siemens is investigating the issue.

Event Description

Two discordant, falsely low ig/l-chain, type kappa results were obtained on two patient serum samples on a bn ii system using n antiserum to human-ig/l-chain, type kappa reagent.The discordant results were reported to the physician(s), and the results were questioned by the physician(s).Each of the two samples was repeated for ig/l-chain, type kappa in a 1:100 dilution using the same system and reagent, resulting higher.The repeat results were reported, as the correct results, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low ig/l-chain, type kappa results.

Manufacturer Narrative

Siemens filed the initial mdr on 20-aug-2019.Additional information (23-aug-2019): siemens further investigated the issue.Based on the analysis of the bn ii system files, a general product problem could be excluded.The result differences were limited to two single patient sample results.A sample characteristic influence could not be excluded, as both affected samples were obtained from multiple myeloma patients.As per the n antiserum to human-ig/l-chain instructions for use (ifu), "the nephelometric determination of human immunoglobulin/l-chains, types kappa and lambda, cannot replace immunoelectrophoresis or immunofixation electrophoresis in the diagnosis of monoclonal gammopathy." results of this test should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.

• Brand Name: N ANTISERUM TO HUMAN-IG/L-CHAIN, TYPE KAPPA
• Type of Device: N ANTISERUM TO HUMAN-IG/L-CHAIN, TYPE KAPPA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 8910151
• MDR Text Key: 159790448
• Report Number: 9610806-2019-00067
• Device Sequence Number: 1
• Product Code: DFH
• Combination Product (y/n): N
• PMA/PMN Number: K943997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

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: 02/21/2021
• Device Model Number: N ANTISERUM TO HUMAN-IG/L-CHAIN, TYPE KAPPA
• Device Catalogue Number: 10446594
• Device Lot Number: 122194
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1