MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1300 ANALYZER

Model Number	ATELLICA IM 1300 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that erroneous total human chorionic gonadotropin (thcg) results were obtained on two patient samples on an atellica im 1300 analyzer.The customer indicated that the system was resulting positive, but samples were negative on repeat on second system.The erroneous results were reported to the physician(s).The samples were reprocessed on an alternate instrument and obtained correct results.It is unknown which instrument was used for repeat testing.It is unknown if the correct results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that erroneous total human chorionic gonadotropin (hcg) results were obtained on two patient samples on a atellica im 1300 analyzer.A siemens customer service engineer (cse) was dispatched to the customer's site.During this visit, the cse found that the tubing was disconnected for wash station 1 (ws1) in, air in lines to all wash pumps, repaired tubing, performed dry to wet prime cycle, ran autocheck, performed im daily maintenance and quality control (qc), which recovered acceptably.The cause of the event is unknown.The normal troubleshooting actions taken care by the cse resolve the event.The instrument is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2025-00143 on 04-jun-2025.Additional information (06-jun-2025): siemens further evaluated the event and concluded that the issue was consistent with air getting into fluidic lines, less wash will be dispensed into the cuvettes, and performing incomplete washes, which potentially cause the reactive results.Section b6 was updated to reflect the additional patient information.The investigation conclusions code in the h6 was updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA IM 1300 ANALYZER
• Common Device Name: ATELLICA IM 1300 ANALYZER
• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22140015
• Report Number: 2432235-2025-00143
• Device Sequence Number: 8139764
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K151792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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 IM 1300 ANALYZER
• Device Catalogue Number: 11066001
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown