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

Model Number	10464525
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdrs 2517506-2019-00452 and 2517506-2019-00453 were filed for the same event.The customer contacted the siemens customer care center (ccc) and reported elevated cardiac troponin i (tni) patient results were obtained on a dimension exl 200 instrument.Siemens is investigating the event.
Event or Problem Description
Elevated a cardiac troponin i (tni) results were obtained on patient serum samples on a dimension exl 200 instrument.The results were reported to the physician(s) who questioned the result.The results obtained were considered correct based on the patient's previous history of a positive tni result.There are no known reports of patient intervention or adverse health consequences due to the elevated tni results.
Additional Manufacturer Narrative
Mdr 2517506-2019-00454 was filed on 03-dec-2019.Mdrs 2517506-2019-00452 and 2517506-2019-00453 were filed for the same event.Additional information (04-feb-2020): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely elevated cardiac troponin i (tni) result.Hsc evaluated the information provided.Additional information was requested from the customer, including message logs, clot check data, chem data, filter data and loci data.The requested data was not provided.No product problem was identified.The instrument is operational.The cause of this event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Supplemental mdrs 2517506-2019-00452 and 2517506-2019-00453 were filed for the same event.

• 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: 9405702
• Report Number: 2517506-2019-00454
• Device Sequence Number: 3231465
• Product Code: MMI
• UDI-Device Identifier: 00842768022067
• UDI-Public: 00842768022067
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K081643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: 05/01/2020
• Device Model Number: 10464525
• Device Catalogue Number: RF621 SMN 10464525
• Device Lot Number: EE0122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1