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

Catalog Number	K6420 SMN 10445097
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant mass creatine kinase mb isoenzyme (mmb) results.Hsc determined that when the customer diluted the 2.5 ng/ml sample with the 1:20 dilution, the recovered value of the instrument was less than 1 ng/ml which was below the value that could be accurately measured by the instrument.The system would then multiply the result by the dilution factor of 20; any recovered value of the diluted sample that is less than 1 ng/ml will give a value of < 20 ng/ml.The dilution protocol is developed for samples that are above assay range.The data does not show why the customer processed the initial samples with a dilution.A dilution was not triggered on the instrument, the dilution was manually entered by the operator.The discordant mmb result was due to the operator inappropriately ordering a dilution on the sample causing the < 20 ng/ml result.The customer did not report issues with any other assays on this instrument.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant mass creatine kinase mb isoenzyme (mmb) result was obtained on a patient sample on the dimension vista system.The result was reported to the physician and was questioned.The same sample was reprocessed the same day and a correct result was obtained.A corrected report was issued.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 VISTA®
• Common Device Name: DIMENSION VISTA® MASS CREATINE KINASE MB ISOENZYME FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8018896
• Report Number: 2517506-2018-00613
• Device Sequence Number: 1195006
• Product Code: JHY
• UDI-Device Identifier: 00842768015328
• UDI-Public: 00842768015328
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2018

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: 06/20/2019
• Device Catalogue Number: K6420 SMN 10445097
• Device Lot Number: 18171BA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1