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

Model Number	10464525
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdrs 2517506-2021-00189, 2517506-2021-00190, and 2517506-2021-00191 were filed for the same event.The customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding discordant falsely elevated cardiac troponin i (tni) results obtained with one patient's samples on a dimension exl w/lm system.Siemens is investigating the event.
Event or Problem Description
Discordant falsely elevated cardiac troponin i (tni) results were obtained with one patient's samples on a dimension exl w/lm system.The discordant results were reported to the physician who questioned the results.One sample was later reprocessed with an alternate, non-siemens methodology and a lower result, considered correct, 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
Siemens headquarters support center completed the investigation of the falsely elevated patient troponin i (tni) result obtained while processing with the dimension exl cardiac troponin assay.The dimension exl instrument data was collected, and a sample was returned to siemens healthineers for evaluation.Tni quality control and calibration were within expectations and there were no instrument malfunctions seen during the processing of the sample.The customer returned patient sample recovered an elevated troponin result when processed with the dimension exl tni assay but and recovered a result within the normal reference range when processed with the dimension exl high sensitivity troponin i (tnih) assay.The patient sample was then treated with a heterophile blocking tube (hbt) and the dimension exl tni result from the pre-treated sample was lower, within the normal range.This result verified that the sample may have a heterophilic antibody interferent that could potentially have produced the discordant elevated result.The dimension exl cardiac troponin i flex reagent cartridge instruction for use (ifu) states the following: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay has been designed to minimize interference from heterophilic antibodies.Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed.A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution." the potential cause of the issue could be a patient specific heterophilic antibody interference.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2021-00188 was filed 17-aug-2021.Mdrs 2517506-2021-00189, 2517506-2021-00190, and 2517506-2021-00191 were filed for the same event.Mdr supplements 2517506-2021-00189 supplement 1, 2517506-2021-00190 supplement 1, and 2517506-2021-00191 supplement 1 were filed for the same event.

• Brand Name: DIMENSION
• Common Device Name: 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: 12334162
• Report Number: 2517506-2021-00188
• Device Sequence Number: 11451667
• Product Code: MMI
• UDI-Device Identifier: 00842768022067
• UDI-Public: 00842768022067
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K081643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 09/17/2021

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: 10/31/2021
• Device Model Number: 10464525
• Device Catalogue Number: RF621 SMN 10464525
• Device Lot Number: EA1304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR