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

Model Number DIMENSION EXL WITH LM

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Event Description

The customer reported liquid from cuvettes dripped onto an operator¿s lab coat and pants while they were troubleshooting a photometer source lamp error on the dimension exl with lm instrument.At the time of filing this report, it is unknown whether the operator¿s skin contacted the contents of the cuvettes.The customer indicated that there were no tear or punctures on the operator's skin and the operator did not seek any medical attention.There are no known reports of adverse health consequences due to this event.

Manufacturer Narrative

A united states customer contacted a siemens customer care center and reported that the photometer source lamp did not initialize on the dimension exl with lm.An operator turned off the instrument, opened the thermal chamber, and removed the malfunctioned source lamp.While attempting to replace the new source lamp, contents of the cuvettes dripped on the operator¿s lab coat and pants.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse replaced the source lamp, performed lamp calibration, and ran a system check and quality control (qc), which recovered acceptably.As per the dimension exl 200 dimension exl with lm operator¿s guide: the cuvettes and the contents of the cuvettes may present a biohazard or chemical hazard.Follow standard laboratory procedures for protection from biohazards and chemicals when performing maintenance and troubleshooting procedures.The customer¿s method in performing the maintenance activity to resolve the malfunctioned photometer source lamp contributed to the event.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION EXL WITH LM
• Type of Device: 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: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 18813101
• MDR Text Key: 336990236
• Report Number: 2517506-2024-00082
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL WITH LM
• Device Catalogue Number: 10486890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1