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 Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and reported that an operator was exposed to the contents of cuvette while performing a maintenance procedure on a dimension exl with lm instrument.The operator was not wearing the protective eyewear.A siemens specialist assisted the customer with rethreading film on the capstan and the customer subsequently called back to report that the film was jammed.A customer service engineer (cse) was dispatched to the customer's site.The cse identified a missing c- clip from the cuvette guide assembly, which prevented the film from being correctly channeled into waste and caused it to tangle in the capstan area.When the operator was un-tangling the spent film, the operator was splashed by the contents of the cuvette.The cse replaced the idler roller assay and inspected numerous cuvettes.The missing c-clip contributed to the operator's exposure to contents of a cuvette.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

An operator of a dimension exl with lm instrument was exposed to contents of a cuvette while loading a new cuvette cartridge canister.The operator was trying to remove the film that was wrapped around capstan when the contents of the cuvette splashed onto the customer's lab coat, gloves and forehead.The operator rinsed her forehead and did not seek medical intervention.The customer reported that there was no impact to patent testing.There are no known reports of adverse health consequences due to the operator's exposure to the contents of cuvette while performing maintenance on the dimension exl with lm.

• 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; 101 silvermine road; registration number: 1226181; brookfield CT 06804
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 8765299
• MDR Text Key: 150837855
• Report Number: 2517506-2019-00276
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• 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: 10808302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2009
• 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