MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC ATELLICA IM 1300

Model Number	ATELLICA IM 1300
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report a falsely elevated high-sensitivity troponin i (tnih) that was obtained on a patient sample on an atellica im 1300 analyzer.The customer indicated that they were experiencing issues with the water supply feeding into this analyzer.Since they were not able to run the ¿end of day¿ quality controls (qcs), they repeated the samples during this period and observed the erroneous result described in section b5.The customer indicated that the water supply issue was resolved, and the customer performed qc, which recovered acceptably.The cause of the erroneous tnih result is unknown.The analyzer is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A falsely elevated high-sensitivity troponin i (tnih) result was obtained on a patient sample on an atellica im 1300 analyzer.The erroneous result was reported to the physician(s), who questioned the result.The same sample was repeated on two different atellica im analyzers.The repeat results were lower than the erroneous result.The patient was redrawn, and the new sample was processed on one of the latter atellica im analyzers.The result from the redrawn sample matched the other repeat results.The repeat result of <2.50 ng/l was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2023-00163 on 15-jun-2023.Additional information (03-jul-2023): the customer refused a service visit as they believed that the water supply disruption to the analyzer contributed to the event.Siemens further evaluated the issue and determined that there was no evidence of an analyzer malfunction.There was also no indication that the analyzer was contaminated by the water supply issue.Since there was only one sample impacted by this event, siemens concluded that preanalytical issues on this sample potentially contributed to the falsely elevated high-sensitivity troponin i (tnih) result.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.

• Brand Name: ATELLICA IM 1300
• Common Device Name: ATELLICA IM 1300
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 17137920
• Report Number: 2432235-2023-00163
• Device Sequence Number: 14435710
• Product Code: JJE
• UDI-Device Identifier: 00630414002347
• UDI-Public: 00630414002347
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151792
• 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): 07/25/2023

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 Model Number: ATELLICA IM 1300
• Device Catalogue Number: 11068008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown