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

Catalog Number	RF520 SMN10444895
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center for the discordant, falsely elevated low volume mass creatinine kinase (lmmb) result on a dimension exl instrument.Siemens headquarters support center (hsc) has completed the investigation of the incident.Hsc evaluated the data provided.No instrument issues have been reported or identified.Lmmb qc was within reference ranges on the date of the incident.This event is limited to a specific patient sample.The cause of the discordant elevated lmmb result is unknown.Per the lmmb flex reagent cartridge instructions for use: "patient samples may contain heterophilic antibodies that could react with 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 from all patient specimens cannot be guaranteed.A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution." the device is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant, falsely elevated mass creatine kinase mb isoenzyme (lmmb) was obtained on a patient serum sample on the dimension exl instrument.The result was reported to the physician who questioned the result.The same sample was sent to an alternate laboratory for testing on an alternate non-siemens methodology and a lower result was obtained.A corrected result was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated lmmb result.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® LMMB 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: 7361129
• Report Number: 2517506-2018-00131
• Device Sequence Number: 18860346
• Product Code: JHY
• UDI-Device Identifier: 00842768013898
• UDI-Public: 00842768013898
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K970343/A003
• 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): 03/22/2018

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: 09/20/2018
• Device Catalogue Number: RF520 SMN10444895
• Device Lot Number: FA8263
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1