MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM; ATELLICA IM SYPHILIS QUALITY CONTROL MATERIAL (SYPH QC) KIT

Model Number	N/A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that qc material splashed onto the operator's hand and under the glove while opening the negative atellica im syphilis quality control (syph qc), lot 066 bottle.The customer stated that while opening the negative qc bottle by squeezing/squirting through the tip, the material splashed because the tip was not present.Upon inspection, no tip was found inside the blue cap and no evidence of leakage was observed inside the box.The other bottle within the same box was intact.The customer also checked additional boxes, which were found to be acceptable.The missing tip was not located.The customer stated that the operator had a pre-existing cut on the hand beneath the glove (not related to this event), which came into contact with the qc material.Day-zero screening for hiv, hepatitis, and syphilis was performed, and follow-up testing to be performed in 3 months.
Additional Manufacturer Narrative
A customer from outside the united states contacted siemens and reported that qc material splashed onto their hand and under their glove while opening the negative atellica im syphilis quality control (syph qc) bottle.Siemens conducted an investigation of the reported event.A subset of available retain samples was inspected to verify proper dispensing nozzle fitment.Of 55 atellica im syph qc sets available, 10 sets were inspected, and proper nozzle fitment was confirmed on all components examined.A review of the batch records for atellica im syph qc kit lot 474361066 confirmed that the correct dispensing nozzle was used during assembly and kitting.The lot was kitted on 06/19/2025 on kitting line 2, which incorporated a checkweigher as part of the kitting process.Kits not meeting the established acceptable weight range underwent inspection.A kit missing a dispensing nozzle would not have met the acceptable weight criteria.The sampling plan was designed to meet an acceptable quality limit (aql) of 1.0%.Based on one reported kit potentially missing a dispensing nozzle, the calculated occurrence rate was (b)(4), which was below the established aql of (b)(4).The customer is operational and the reported issue was resolved through kit replacement.

• Brand Name: ATELLICA IM
• Common Device Name: ATELLICA IM SYPHILIS QUALITY CONTROL MATERIAL (SYPH QC) KIT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney st.; registration# 1219913; east walpole MA 02032
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 24338703
• Report Number: 1219913-2026-00038
• Device Sequence Number: 9754558
• Product Code: JJX
• UDI-Device Identifier: 00630414599892
• UDI-Public: (01)00630414599892(10)474361066(17)260416
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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): 02/13/2026

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 Expiration Date: 04/16/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995676
• Device Lot Number: 474361066
• 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: 01/20/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown