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

Model Number	ATELLICA SAMPLE HANDLER PRIME
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center to report a sample identifier (sid) mismatch failure on the atellica sample handler (sh) prime tube characterization station (tcs).Siemens evaluated the event and generated example barcodes for sid (b)(6) and sid (b)(6) for comparison.The difference between the barcodes appears in only a small portion of the printout and involves a variation in a single bar/space.The barcode label used for sid (b)(6) was read incorrectly by the tcs due to imperfect printing quality and the barcode symbology in use.During re-introduction of the tube, the tcs likely captured a different portion of the barcode and correctly identified the tube as sid (b)(6).The customer uses interleaved 2 of 5 without checksum, which is not a recommended barcode type per auto2-a2 laboratory guidelines and the site planning guide.If interleaved 2 of 5 is used, a checksum must be enabled.Atellica labeling recommends using code 128 and aligns with clsi approved standards, which state that i2of5, codabar, and code 39 should have been replaced with code 128 before (b)(6) 2003.Siemens concluded that the cause of the reported issue is a use error.The instrument is performing as expected with no hardware or software issues.Visual inspection of the tube barcode shows that the customer site is using interleaved 2 of 5 barcode symbology without checksum and a 10-digit length, printed by a third-party barcode printer not affiliated with atellica solution.The printing shows inconsistent quality, with artifacts on the black bars and slight impurities.The barcode misread error resulted from the use of an insecure barcode symbology combined with a weak printout.No further evaluation of this device is required.
Event or Problem Description
The customer reported that the barcode of the sample with the sample identifier (sid) (b)(6) was read by the atellica sample handler tube characterization station (tcs) as sid (b)(6) causing a sample identifier (sid) mismatch failure.The customer noticed 2 different sets of results for patient with sid (b)(6).There were 3 minutes between the 2 results using different rack numbers and position records.Sample id (b)(6), first results from line 1 were correct.Second set of results 3 min later from line 2 were not correct and from a different patient with sid (b)(6).There are no known reports of patient intervention or adverse health consequences due to the sid mismatch failure.

• Brand Name: ATELLICA SAMPLE HANDLER PRIME
• Common Device Name: ATELLICA SAMPLE HANDLER PRIME
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 24363209
• Report Number: 2432235-2026-00052
• Device Sequence Number: 10200676
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: (01)00630414002439
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 02/17/2026

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: 01/27/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2020
• 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