MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LOCI MODULE (LM) AND SAMPLE TRANSFER MODULE (STM); DIMENSION EXL WITH LM STM

Model Number	DIMENSION WITH LM STM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The operator of a dimension exl with loci module (lm) and sample transfer module (stm) instrument contacted siemens to report that sparks were observed while performing maintenance on the air manifold and heat torch.The siemens customer care center advised the customer to power off the instrument before proceeding.Siemens headquarters support center reviewed the available information and concludes that the operator did not turn off power to instrument before starting the maintenance activities as described in the operator's manual.The cause of the observed sparks was a use error.The instrument is performing within specifications.No further evaluation of the instrument is needed.
Event or Problem Description
Two sparks were observed by the operator of a dimension exl with loci module (lm) and sample transfer module (stm) instrument while performing maintenance on the air manifold and heat torch.There are no known reports of patient intervention or adverse health consequences due to the observed sparks.

• Brand Name: DIMENSION EXL WITH LOCI MODULE (LM) AND SAMPLE TRANSFER MODULE (STM)
• Common Device Name: DIMENSION EXL WITH LM STM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 10356319
• Report Number: 2517506-2020-00239
• Device Sequence Number: 2841592
• Product Code: JJE
• UDI-Device Identifier: 00630414593593
• UDI-Public: 00630414593593
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

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 WITH LM STM
• Device Catalogue Number: 10639337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1