MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR HIGH SENSITIVITY TROPONIN I (TNIH) ASSAY; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states customer reports observation of discordant elevated advia centaur high-sensitivity troponin i (tnih) result for one patient.The initial result was reported to physician(s), who questioned the result.The sample was repeated on different alternate methods (for troubleshooting purposes) and the results were comparable to the initial result except for one alternate method testing.The interpretation of results section of the advia centaur tnih instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens continues to investigate.
Event or Problem Description
The customer obtained a discordant elevated advia centaur high-sensitivity troponin i (tnih) result for one patient.The initial result was reported to physician(s), who questioned the result.The sample was repeated on different alternate methods (for troubleshooting purposes) and the results were comparable to the initial result except for one alternate method testing.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant tnih results.
Additional Manufacturer Narrative
Initial mdr 2432235-2023-00161 was filed on jun 15, 2023.Additional information ¿ jun 30, 2023: the customer observed a repeatedly elevated (>ifu 45 pg/ml 99th% reference) advia centaur tnih value for a patient that was low/normal on an alternate method.Quality control (qc) was within acceptable limits.Advia centaur result: 314.2 ng/l (male reference cutoff: 53.5 ng/l).Alternate method 1 result: 256.6 ng/l (reference interval 0¿60.4 ng/l).Alternate method 2 result: 228 pg/ml (ng/l) (male reference range: 34 ng/l).Alternate method 3 result: 258 ng/l (male reference range: 39 ng/l).Alternate method 4 result: 6.4 pg/ml (ng/l) (reference range: 19.8 ng/l).Alternate method 5 result: 160 ng/l (reference range: 160 ng/l).All methods yielded results on this patient were > reference interval except for alternate method 4.Siemens ran a returned sample from the patient neat and after treatment with heterophile binding tube (hbt).The neat result was 351.77 pg/ml (ng/l), which is consistent with the customer's observed recovery.There was no appreciable change in dose after treatment with the hbt, indicating the absence of a heterophile antibody as the cause for the elevated result.Per the instruction for use (ifu), there are conditions, cardiac and non-cardiac, other than acute myocardial infarction (ami), that are known to cause myocardial injury and elevated troponin i values.No potential product issue has been observed.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ADVIA CENTAUR HIGH SENSITIVITY TROPONIN I (TNIH) ASSAY
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17133690
• Report Number: 2432235-2023-00161
• Device Sequence Number: 6448256
• Product Code: MMI
• UDI-Device Identifier: 00630414602929
• UDI-Public: 00630414602929
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K171274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 03/15/2024
• Device Model Number: N/A
• Device Catalogue Number: 10994775
• Device Lot Number: 087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown