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

Catalog Number	RF621 SMN 10464525
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdrs 2517506-2019-00388 and 2517506-2019-00390 were filed for the same event.The customer contacted the siemens customer care center (ccc) and reported discordant falsely elevated cardiac troponin i (tni) patient results were obtained on a dimension exl 200 instrument.Siemens healthcare diagnostics headquarters support center (hsc) completed the investigation of the event.Hsc has reviewed the information provided and the instrument data.No product non-conformance was identified.The patient sample was requested be returned to the siemens technical support laboratory for evaluation.The returned sample produced a troponin value of 0.113 ng/ml which did not change when treated with the heterophile blocking pre-treatment (hbt).The data shows that the patient produces a repeatedly elevated result with the dimension exl tni assay that is not consistent with alternate non-siemens methodologies and clinical presentation of the patient.The cause of the event in is unknown.The system is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant, falsely elevated cardiac troponin i (tni) result was obtained on a patient serum/plasma sample on a dimension exl 200 instrument s/n (b)(4).The result was not reported to the physician(s).A prior lower result from the same patient on an alternate siemens instrument s/n (b)(4) was reported to the physician(s) who questioned the result.The same sample was reprocessed on at an alternate facility and obtained a lower result which was considered correct.There are no known reports of patient intervention or adverse health consequences due to the discordant tni results.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION® TNI CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• MDR Report Key: 9181901
• Report Number: 2517506-2019-00389
• Device Sequence Number: 11453854
• Product Code: MMI
• UDI-Device Identifier: 00842768022067
• UDI-Public: 00842768022067
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 10/11/2019

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: 03/28/2020
• Device Catalogue Number: RF621 SMN 10464525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR