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

Model Number	N ANTISERUM TO HUMAN IGM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens healthcare diagnostics inc.(siemens) customer service engineer (cse) was dispatched to the customer site to determine the cause of the different igm results obtained the patient sample on the bn ii system and found no issues.Similar results were obtained on both systems and the internal quality controls recovered within range, indicating a sample issue.The customer agreed that this issue is sample specific.The customer reported that they have not received any complaints from any physicians.The customer powered down the system since the original patient samples were run and the kinetics and original patient sample were not available for further investigation.The instruments and reagents are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A flagged high immunoglobulin m (igm) result was obtained on a patient sample on the bn ii system.The same patient sample was diluted using multiple dilution ratios and run on the same bn ii system.Different igm results were obtained on these samples and the results were dilution ratio dependent.The same patient sample was respun and run with multiple dilutions on an alternate bn ii system.The results obtained on the alternate bn ii system matched the results obtained on the original system.An igm result of 508.0 mg/dl was reported to the physician.The customer indicated that the correct result for this patient is unknown since they do not have the patient's clinical history.There are no known reports of patient intervention or adverse health consequences due to the flagged high igm result on this patient sample.

• Brand Name: N ANTISERUM TO HUMAN IGM
• Common Device Name: N ANTISERUM TO HUMAN IGM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 6840149
• Report Number: 9610806-2017-00096
• Device Sequence Number: 1117258
• Product Code: CFN
• UDI-Device Identifier: 00842768009846
• UDI-Public: 00842768009846
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2019
• Device Model Number: N ANTISERUM TO HUMAN IGM
• Device Catalogue Number: 10446303
• Device Lot Number: 153226F
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1