MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

Model Number	DIMENSION EXL WITH LM
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report that a sample was dispensed in the incorrect aliquot position on the dimension exl with lm instrument.A siemens customer service engineer (cse) was dispatched to the customer¿s site.The cse checked alignments, the sample arm and the sample transfer module (stm) and reviewed logs.The cse replaced the assembly motor encoder, home sensor, and the motor control board.After the service actions performed by the cse, there were no further reoccurrences of the event.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 a sample was dispensed into an incorrect aliquot position on the dimension exl with lm instrument, which caused a delay in testing the patient sample as the sample needed to be repeated.The instrument triggered the following error codes: ¿sample arm cannot detect sample¿ and ¿error check level¿.Then, the instrument cancelled the aliquot position and aliquoted the sample correctly in a new aliquot well.The sample was tested, and correct patient results were reported.There are no known reports of patient intervention or adverse health consequences due to the reported event.

• Brand Name: DIMENSION EXL WITH LM
• Common Device Name: DIMENSION EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• 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: 17961445
• Report Number: 2517506-2023-00221
• Device Sequence Number: 20092133
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: 00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K130276
• 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): 10/18/2023

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: DIMENSION EXL WITH LM
• Device Catalogue Number: 10472176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/18/2023
• 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