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	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2019-00442 was reported for the same event.The customer contacted the siemens customer care center (ccc) and reported a discordant elevated cardiac troponin i (tni) patient result on a dimension vista instrument.Siemens healthcare diagnostics headquarters support center (hsc) is investigating the event.
Event or Problem Description
A discordant elevated cardiac troponin i (tni) result was obtained on a patient sample on a dimension vista instrument.The result was reported to the physician(s) who questioned the result and sent the patient to an alternate facility for a new sample to be drawn.There are no known reports of patient intervention or adverse health consequences due to the discordant tni result.
Additional Manufacturer Narrative
Mdr 2517506-2019-00444 was filed on 02-dec-2019.Mdr 2517506-2019-00442 was also filed for the same event on 02-dec-2019.Additional information (13-dec-2019): 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 and the instrument data files.The customer performed a patient sample troubleshooting study by processing the sample with serial dilutions of 1:2, 1:4 and 1:8 indicating the customer was aware of potential antibody interference with this patient's sample.The diluted results indicated a linear dilution which is atypical for antibody interference.The customer sent sample from the patient out to a reference lab that used a non-siemens alternate methodology.The non-siemens alternate methodology recovered an elevated troponin value of 0.13 ng/ml which was above the 99th percentile for the alternate methodology.Hsc requested the sample to be returned to siemens for additional evaluation, but the sample was not available for return.The cause of the discordant tni result was determined to be due to a sample specific interferent that cannot be further identified with the available data.The instrument is operational.No product non-conformance identified.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.

• 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 19714 6101
• MDR Report Key: 9397376
• Report Number: 2517506-2019-00444
• Device Sequence Number: 3462094
• Product Code: MMI
• UDI-Device Identifier: 00842768022067
• UDI-Public: 00842768022067
• Combination Product (Y/N): N
• 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): 01/08/2020

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: 07/30/2020
• Device Catalogue Number: RF621 SMN 10464525
• Device Lot Number: EE0185
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR