MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA); TROPONIN IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the falsely low tni ultra result on a patient sample is unknown.Siemens reviewed available information to determine potential root cause.The patient's prior result was elevated so a low/negative result was not expected.Qc run shortly after this patient sample was within acceptable limits.No other samples were affected.There is no sample remaining for further investigation.Siemens also reviewed all relevant system files and found no issue that would cause the falsely low result nor did the customer service engineer on site find any system issues when he checked the instrument.The sample was only spun for 7 minutes which may be an abbreviated spin.Preanalytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.While there is insufficient information to determine the cause of the false results, preanalytic factors leading to fibrin interference cannot be ruled out as the causative agent.No product performance issue is confirmed.The customer is operational.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
Customer observed a low atellica im 1300 troponin i ultra (tni-ultra) result that did not match repeat testing or the clinical picture of the patient.The low result was reported the physician who questioned the result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the low atellica im 1300 tni-ultra result.

• Brand Name: ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA)
• Common Device Name: TROPONIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9126099
• Report Number: 1219913-2019-00177
• Device Sequence Number: 11412436
• Product Code: MMI
• UDI-Device Identifier: 00630414600093
• UDI-Public: 00630414600093
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K053020
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

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: 04/14/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995696
• Device Lot Number: 07998164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1