MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION® TNI CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE

Model Number	DIMENSION® EXL¿ 200
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) about falsely elevated cardiac troponin i (tni) results obtained on a dimension exl 200 system.Siemens is evaluating the event.Mdrs 2517506-2020-00227 and 2517506-2020-00228 were filed for the same event.
Event or Problem Description
Discordant, falsely elevated cardiac troponin i (tni) results were obtained on a patient's samples on a dimension exl 200 instrument.The discordant results were reported to the physician.The same samples were processed on an alternate non-siemens methodology and lower results were obtained.The patient was sent to a hospital where a ct coronary angiogram, ekg, and a chest x-ray were performed.There are no known reports of adverse health consequences due to the falsely elevated tni results or treatments.
Additional Manufacturer Narrative
Mdr 2517506-2020-00227 supplement 1 and 2517506-2020-00228 supplement 1 were filed for the same event.Additional information (10-aug-2020): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the event.Hsc evaluated the information provided and the instrument data.The instrument data did not indicate any malfunction with the loci¿ detector system, reagent delivery or sample system on the dimension exlanalyzer.The testing data shows that the samples perform differently between reagent lot: eb1045 and ee0345.This pattern of recovery seen is consistent with a patient specific interferent such as an heterophilic antibody.The samples were unavailable for return to siemens.Quality control (qc) and calibration were within expectations at the time of the incident.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Original mdr was filed 30-jul-2020.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION® TNI CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 10344772
• Report Number: 2517506-2020-00229
• Device Sequence Number: 13668107
• Product Code: MMI
• UDI-Device Identifier: 00842768022067
• UDI-Public: 00842768022067
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081643
• 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,Followup
• Report Date (Section B): 08/24/2020

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: 12/10/2020
• Device Model Number: DIMENSION® EXL¿ 200
• Device Catalogue Number: RF621 SMN 10464525
• Device Lot Number: EE0345
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1