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	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center for the discordant depressed low volume mass creatinine kinase (lmmb) serum result on the dimension exl instrument.Quality control was within specification during testing.Siemens headquarters support center (hsc) has completed the investigation of the incident.Hsc evaluated the data provided.The data is consistent with a patient specific lmmb interferent occurring without instrument issues or qc inaccuracy.Complaint patient sample demonstrates a repeatable difference in lmmb recovery when testing serum and plasma samples obtained during the same venipuncture.No product non-conformance was found.Per 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 patient sample demonstrated a repeatable difference in low volume mass creatinine kinase (lmmb) recovery when testing serum and plasma samples obtained during the same venipuncture.A discordant falsely depressed serum result for lmmb was obtained on the patient serum sample and a higher result was obtained on the plasma sample both processed on the dimension exl instrument.The initial serum and plasma results were not reported to the physician.The repeated serum and plasma results correlated with the initial results.The repeat testing on the original serum sample obtained a lower result than the result obtained on the plasma sample.The repeat plasma sample was reported and not questioned.There is no known report of patient intervention or adverse health consequences due to the discordant falsely depressed serum 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: 7278372
• Report Number: 2517506-2018-00068
• Device Sequence Number: 13954799
• Product Code: JHY
• UDI-Device Identifier: 00842768013898
• UDI-Public: 00842768013898
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 02/16/2018

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: 01/24/2018
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1