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

Model Number	ATELLICA SAMPLE HANDLER PRIME
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that a pediatric sample (sid(b)(6) was misread and processed against a different sample (sid(b)(6) on the atellica sample handler prime system with serial number (b)(6).The customer stated the issue occurred on (b)(6) 2024 at 11:15 am and that sid(b)(6) was front-loaded and identified as sid (b)(6), and the worklist for sid (b)(6) was processed.Siemens has been informed that sid (b)(6) was not presented to the atellica system at the time of the event.The customer uses code128 as the barcode symbology, and the width of the label used with the sample tube appears narrow at 7.2mm, which is a potential issue.The laboratory has used labels with a measured width of 6mm.However, the customer has encountered barcode read errors on an alternate system and stated that no wrong sample ids were read and has stopped using barcode labels with a measured width of 6mm.Siemens is investigating the event.
Event or Problem Description
The customer reported that a pediatric sample (sid (b)(6) was misread and processed against a different sample (sid (b)(6) on the atellica sample handler prime system with serial number (b)(6).The customer stated the issue occurred on (b)(6) 2024 at 11:15 am and that sid (b)(6) was front-loaded and identified as sid (b)(6), and the worklist for sid 59249085 was processed.The customer informed siemens that the incorrect results had been released and were questioned by the physician(s).The customer stated that there was a delay in analysis because the limited pediatric sample volume depleted and decided not to rebleed the infant until the next day.The customer has performed repeat testing and issued a corrected report.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2024-00234 on 18-oct-2024.Additional information (10-jan-2025): siemens investigated the event and noted that the tube characterization station (tcs) barcode misread sample id (b)(6) due to the customer using unapproved 6-7 mm barcode labels.The required minimum barcode width/height is 10 mm, specified in the customer's online help documentation.Siemens also identified a bar/space discrepancy within the barcode itself.When comparing the bars and spaces with the correct (b)(6) barcode, a wide black bar in the (b)(6) barcodes appeared compromised and split into two black bars instead of one wide bar, potentially due to an issue with the barcode printer.Siemens concluded that the cause of the event was a use error and the use of a barcode label that did not meet the requirements.The atellica sample handler prime system is fully functional and performs as specified, and no further evaluation was required.Siemens updated section h6 (investigation conclusion) to reflect the additional information.

• 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.; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 20483122
• Report Number: 2432235-2024-00234
• Device Sequence Number: 3519506
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: (01)00630414002439
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K161954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• 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): 01/17/2025

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): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown