MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION EXL 200

Device Problem Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The ccc specialist was informed that the cuvette film was not removed and caused the instrument to jam.While troubleshooting, the customer accidentally squeezed a used cuvette and was splashed with waste fluid in the left eye.The customer was wearing regular glasses and stated that safety glasses were not worn.The customer rinsed the eye at an eye flush station and was examined by an onsite physician.The physician checked the customer's eye, and there was no injury, no redness, and no treatment was required.The event was documented internally in the lab.The instrument jam was cleared by the customer.The instrument is fully operational.No further evaluation of this device is required.

Event Description

The customer was troubleshooting a cuvette film jam on the dimension exl 200 instrument and was splashed with waste fluid in the left eye.The customer immediately rinsed the eye at an eye flush station and was examined by an onsite physician.The physician determined that no treatment was required.There are no reports of adverse health consequence due to the exposure to waste fluid.

• Brand Name: DIMENSION EXL 200
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• 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 #: 1226181; brookfield CT 06804
• Manufacturer Contact: rolando hualpa ; 511 benedict ave; tarrytown, NY 10591 ; 9145242963
• MDR Report Key: 7754864
• MDR Text Key: 116717561
• Report Number: 2517506-2018-00441
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414593579
• UDI-Public: 00630414593579
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073604
• 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: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL 200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2013
• 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