MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SAMPLE HANDLER PRIME

Model Number	ATELLICA SAMPLE HANDLER PRIME
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An atellica sample handler prime customer noted that sample (b)(6) received at 12:39 p.M.On 31-oct-2023 was not processed and analyzed with tnih (high-sensitivity troponin i) and caused a delay in the assessment of the patient.The customer performed repeat testing and noted that the sample was tested on an alternate atellica analyzer.The tnih result was obtained at 16:14 p.M.And released from the lab at 16:25 p.M.On 31-oct-2023.Siemens retrieved system files and is evaluating the event.
Event or Problem Description
An atellica sample handler prime customer noted that sample (b)(6) received at 12:39 p.M.On 31-oct-2023 was not processed and analyzed with tnih (high-sensitivity troponin i) and caused a delay in the assessment of the patient.The customer performed repeat testing and noted that the sample was tested on an alternate atellica analyzer.The tnih result was obtained at 16:14 p.M.And released from the lab at 16:25 p.M.On 31-oct-2023.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2023-00294 on 10-nov-2023.Additional information (16-jul-2024): siemens reviewed the information provided and determined that the atellica immunoassay (im) analyzer was in an "off state" due to a device manager layer (dml) internal exception.The module manager (mm) detects that the device management layer (dml) is unresponsive and restarts.Upon restart, any uncompleted tests are canceled.In cases where the system does not return to normal operation automatically, the operator can turn mechanics off/on or restart the system and re-order the tests manually.Siemens concluded that the reported behavior was caused by an internal software exception and resulted in an apparent delay that failed safe by canceling unreported tests and not affecting test result accuracy.Siemens noted that the event was an isolated occurrence and that the customer has a backup analyzer or alternate method to test patient samples and report results.

• Brand Name: ATELLICA SAMPLE HANDLER PRIME
• Common Device Name: ATELLICA SAMPLE HANDLER PRIME
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd.; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 18112592
• Report Number: 2432235-2023-00294
• Device Sequence Number: 7633635
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: 00630414002439
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161954
• 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): 07/26/2024

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 SAMPLE HANDLER PRIME
• Device Catalogue Number: 11069001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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