MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION®; DIMENSION® IGM IMMUNOGLOBULIN M FLEX® REAGENT CARTRIDGE

Catalog Number	K7058 SMN 10445904
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely depressed immunoglobulin m (igm) result.The instructions for use for igm states the following: "monoclonal immunoglobulins may show reactivity different from the polyclonal calibrator, which in isolated cases may lead to artificially decreased or non-linear results".Based on the performed analysis there is no indication that a general product issue exists.The same igm flex wells were used to run other patient samples as well as qc and no further discrepant results were observed.The issue is limited to one specific patient who is known to have a monoclonal component.The cause is unknown.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant, falsely depressed immunoglobulin m (igm) result was obtained on a patient sample on the dimension vista 1500 system.The result was reported to the physician(s).The same sample was reprocessed the same day and a higher result was obtained and a corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant igm result.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® IGM IMMUNOGLOBULIN M FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. bos 6101; newark DE 19714 6101
• MDR Report Key: 8197844
• Report Number: 2517506-2018-00714
• Device Sequence Number: 1770841
• Product Code: CFN
• UDI-Device Identifier: 00842768006197
• UDI-Public: 00842768006197
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K090594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2018

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: 12/12/2019
• Device Catalogue Number: K7058 SMN 10445904
• Device Lot Number: 18173MA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1