MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION®; DIMENSION® MMB MASS CREATINE KINASE MB ISOENZYME FLEX® REAGENT CARTRIDGE

Catalog Number	RF420 SMN10444904
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2017-00841 was also filed for the same customer inquiry.Quality control was within laboratory range on the date of testing.The ifu for dimension vista® ctni flex® reagent cartridge contains the following information: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay has been designed to minimize interference from heterophilic antibodies.Nevertheless, complete elimination of this interference cannot be guaranteed.A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution." siemens headquarters support center (hsc) has concluded their investigation with root cause unknown.There is no indication of a product issue.No further evaluation of the device is required.
Event or Problem Description
A discordant elevated mass creatine kinase mb isoenzyme (mmb) result was obtained on a patient sample on the dimension exl system.The initial result was reported to the physician and not questioned.The same sample was diluted and tested on the first specimen and both repeated results were elevated.A 1:3 dilution performed on the second specimen obtained a lower result; however was still elevated.The sample was tested on an alternate methodology on a non-siemens instrument and a lower result was obtained.The customer did not know what alternate methodology or instrument was used when the sample was sent out for testing.No treatment was provided to the patient on the basis of the reported discordant result.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated mmb result.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® MMB MASS CREATINE KINASE MB ISOENZYME FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• MDR Report Key: 7061805
• Report Number: 2517506-2017-00840
• Device Sequence Number: 1423489
• Product Code: JHY
• UDI-Device Identifier: 00842768013829
• UDI-Public: 00842768013829
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K970343
• 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): 11/27/2017

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: 06/19/2018
• Device Catalogue Number: RF420 SMN10444904
• Device Lot Number: FB8170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1