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

Catalog Number	RF420 SMN 10444904
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the discordant elevated mmb result is unknown.Customer care center (ccc) analysis of the data shows imprecision as the sample was rerun.Values ranged from just below the assay upper assay range to values greatly above the range.Cki and tni were run on same patient and no issues were reported with the patient results.Quality control was within laboratory range on the date of testing.Siemens is investigating the incident.
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 repeated result >600 ng/ml was reported to the physician and not questioned.The same sample was auto-diluted and elevated results were obtained.Manual dilution of the sample (2x and 5x) obtained lower results.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated mmb result.
Additional Manufacturer Narrative
The original mdr 2517506-2017-00569 was filed on 2017-07-19.Analysis of the instrument and instrument data indicate that the cause for the discordant elevated mass creatine kinase mb isoenzyme result is unknown.A siemens healthcare diagnostics headquarters support center (hsc) representative evaluated the information and found that the original patient value is discordant with the manually diluted repeat value and value obtained on the alternate methodology.Hsc confirmed there was no product issue and product performed as designed.The instructions for use for the mass creatine kinase mb isoenzyme 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." the instrument is performing within specifications.No further evaluation of the device is required.

• 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: 6724346
• Report Number: 2517506-2017-00569
• Device Sequence Number: 531845
• Product Code: JHY
• UDI-Device Identifier: 00842768013829
• UDI-Public: 00842768013829
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 08/16/2017

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: 04/03/2018
• Device Catalogue Number: RF420 SMN 10444904
• Device Lot Number: FB8093
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR