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	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states (ous) customer called siemens customer care center (ccc) and reported that there was a misread sample barcode on the atellica sample handler prime that led to the reporting of the one patient¿s results for another patient.The customer is knowingly utilizing a non-preferred barcode type without checksums.The informatics service will add the checksum to the sample tube barcodes to prevent recurrence.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The alanine aminotransferase p5p (altplc), gamma-glutamyl transferase (ggt), enzymatic creatinine_3 (ecre3), aspartate aminotransferase p5p (astplc), wide range c reactive protein (wrcrp), hemolysis, icterus, lipemia (h, i, l) and thyroid stimulating hormone 3-ultra (tsh3ul) results associated with the sample identified as (b)(6) were reported as the results for the sample identified as (b)(6) when the tube characterization station (tcs) on an atellica sample handler prime misread the barcode.The results were reported to the physician.The customer repeated the sample identified as (b)(6).There were no reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2024-00012 with the fda on 22-jan-2024.Additional information (25-jan-2024): it was determined that the customer was using interleaved 2 of 5 without checksum.The picture of the sample tube in question was not available for evaluation.Therefore, the quality of the print is unknown.Interleaved 2 of 5 barcode symbology without checksums barcode type is not recommended per auto2-a2 laboratory guidelines.If interleaved 2 of 5 barcode symbology is used, a checksum must be enabled.Interleaved 2 of 5 has a known defect, making it possible for a short scan that begins in the middle of the barcode to begin with a pattern that corresponds to the required start pattern, or for a short scan that ends in the middle of the barcode to end with a pattern that corresponds to the required stop pattern.Therefore, the short scan, though incorrect, may appear to be a correct full scan.Code 128 is always printed with a check digit and has a unique start/stop pattern, making it the preferred/recommended barcode type.The lack of a check sum on the interleaved 2 of 5 barcode potentially resulted in the barcode mismatch.The instrument is performing according to specifications.No further evaluation of this device is required.

• 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: douglas stanton ; 511 benedict avenue; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 18559636
• Report Number: 2432235-2024-00012
• Device Sequence Number: 6660714
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: 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,Followup
• Report Date (Section B): 02/05/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/05/2024
• 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