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	11/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2019-00467 was 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
Discordant falsely elevated cardiac troponin i (tni) results were obtained on a patient's serum and plasma samples on a dimension exl 200 instrument.The discordant results were reported to the physician(s) and questioned.Whole blood sample from the same patient was processed again on the non-siemens alternate methodology and a lower result was obtained.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely elevated tni results.
Additional Manufacturer Narrative
Mdr 2517506-2019-00464 was filed on 12-dec-2019.Mdr 2517506-2019-00467 was filed for the same event.Additional information (18-dec-2019): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely elevated cardiac troponin i (tni) results.Hsc evaluated the information provided and the instrument data files.There was no indication of discordant results observed when comparing the non-siemens alternate methodology to the dimension exl troponin method.The dimension exl and non-siemens alternate methodology tni results were both above the 99th percentile of the respective tni methods.There is no claimed numerical correlation between the siemens serum/plasma methodology and the non-siemens whole blood methodology.The results indicated a bias between the serum and plasma samples.The customer performed precision testing and serum /plasma linearity-correlation testing.The customer stated the results meet expectations and did not indicate a systemic bias with serum or plasma.No test results were provided by the customer to siemens.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 results is unknown.No product non-conformance identified.The device is performing within specifications.No further evaluation is required.

• 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: 9460943
• Report Number: 2517506-2019-00464
• Device Sequence Number: 16912236
• Product Code: MMI
• UDI-Device Identifier: 00842768022067
• UDI-Public: 00842768022067
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/10/2020

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: 03/28/2020
• Device Catalogue Number: RF621 SMN 10464525
• Device Lot Number: EB0088
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1