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

Model Number	ATELLICA IM 1300 ANALYZER
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted siemens customer care center (ccc) and reported that during manual maintenance of the atellica im 1300 analyzer, the back cover of the immunoassay module (im) did not remain open and hit the back of the operator¿s head.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse adjusted the adjustment screws on both sides of the lid, checked the lid function and made sure it's not loose and it is holding at the up positions, mid and full open, the lid was secured, and no errors occurred.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that during manual maintenance of the atellica im 1300 analyzer, the back cover of the immunoassay module (im) did not remain open and hit the back of the operator¿s head, causing pain for 2 days.The operator visited employee health for an initial evaluation, and the physician evaluated operator and verified that operator did not have a concussion.There was no injury beyond the hit to the operator's head.It is unknown if the operator required medical intervention.There are no known reports of adverse health consequences due to this event.

• 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.; registration #: 2247117; 62 flanders bartley rd; 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: 23987838
• Report Number: 2432235-2026-00005
• Device Sequence Number: 19991093
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 01/07/2026

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 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: 12/19/2025
• Initial Report FDA Received Date: 01/07/2026
• 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